Clinical Research Management in Regulatory Environment

Press Announcements FDA to approve shared system REMS for TIRF products

2012-01-03T20:49:00.000-08:00

Press Announcements FDA to approve shared system REMS for TIRF products

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Consumer Updates Nov. 30 Webinar: How FDA Regulates Imported Products

2011-11-29T13:50:00.000-08:00

Consumer Updates Nov. 30 Webinar: How FDA Regulates Imported Products

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CDRH Strategic Planning CDRH 2011 Strategic Priorities

2011-11-13T19:43:00.000-08:00

CDRH Strategic Planning CDRH 2011 Strategic Priorities

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Consumer Updates A Glimpse at 'Gluten-Free' Food Labeling

2011-08-02T17:05:00.000-07:00

Consumer Updates A Glimpse at 'Gluten-Free' Food Labeling

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FDA's measures to foster Device Innovation, Safety and Effectiveness

2011-07-04T21:09:00.000-07:00

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The links below provide information on steps CDRH is taking to foster medical device innovation and assure the safety and effectiveness of medical technologies used in the United States. Check out the link below to understand FDA's recommendations for updated Medical Device safety and effectiveness guidelines.

CDRH Plan of Action for 510(k) and Science

Organization for Economic Cooperation and Development (OECD)

2011-02-21T19:27:00.000-08:00

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OECD includes member countries throughout North America, Europe and Asia and has developed guidelines very similar to FDA GLP regulations. OECD regulations are applicable to nonclinical safety studies for pharmaceutical products, animal drugs and food additives, but unlike the FDA GLPs, the OECD regulations are also applicable to studies to evaluate the safety of pesticides and industrial chemicals.

Reference: Fundamentals of US Regulatory Affairs, Sixth Edition

Food Safety Bill: A major overhaul of the Food Safety System

2011-01-18T20:12:00.000-08:00

BayBiotech.NET
The recently passed Food Safety bill is being considered to be a major overhaul of the food safety system in the United States and is considered to change the mission of the FDA, focusing it on preventing food-borne illnesses rather than reacting after an outbreak occurs.
Under this legislation, food manufacturers are required to examine their processing systems to identify possible ways that food products can become contaminated and to develop detailed plans to keep that from happening. Companies must share those plans with the F.D.A., and provide the agency with records, including product test results, showing how effectively they carry them out.

To read more about it follow the link

Personalized Medicine: A Fact Sheet

2010-11-13T22:03:00.000-08:00

BayBiotech.NET
A good read on Personalized Medicine:
http://www.nigms.nih.gov/Initiatives/PGRN/Background/FactSheet.htm

FDA on Facebook and Flickr

2010-10-07T20:48:00.000-07:00

BayBiotech.NET
Visit the new FDA page at: www.facebook.com/fda.The page will provide regular updates on FDA news and events as well as Federal health and safety information of interest to the public.
Also, FDA is taking its public health message to Flickr. Visit FDA on Flickr at: www.flickr.com/photos/fdaphotos/.

Unapproved or Uncleared Devices

2010-09-12T20:13:00.000-07:00

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Legal export provisions become applicable only when a device has not been approved or cleared for domestic marketing. Except 21CFR 812.18, no regulations have been codified to establish how the export of unapproved devices must be managed.

An unapproved deivce must meet the following criteria in order to qualify the for legal export:

1. meet the foreign purchaser's specifications

2. not be in conflict with the importing country's laws

3. be labeled," intended for export only" on the outside of the shipping package

4. not be sold or offered for sale in domestic commerce

Reference: Fundamentals of US Regulatory Affairs, Sixth Edition (Regulatory Affairs Professional Society).

Public Health Emergency Medical Countermeasures

2010-08-29T20:05:00.000-07:00

BayBiotech.NET
US government has faced challenges in producing medical countermeasures for emerging infectious diseases, pandemics, and bioterrorism that carry the potential for catastrophic impact. President called out the renewed need for a national capability to respond to these threats in the State of the Union, and the Secretary of HHS stepped forward to address this need with new strategies that envision a capabilities-based approach with an active role by the U.S. government in forging partnerships, modernizing regulatory oversight, and supporting transformative technologies. To read about the Medical countermeasure strategies click here.

Voluntary Cosmetic Registration Program (VCRP)

2010-08-01T20:44:00.000-07:00

Although cosmetic companies are not subject to mandatory establishment registration or ingredient reporting but they may voluntarily register their establishments and their product compositions through FDA’s Voluntary Cosmetic Registration Program (VCRP). Data provided by Cosmetic Companies through the VCRP helps the agency to prioritize its safety testing program. Anyone can have access to the information registered with VCRP through the Freedom of Information Act. Registration with VCRP also enables agency to notify cosmetics companies about potential problems with the ingredients in their products and helps the agency with inspections that may be necessary. However, registration with VCRP is prohibited from being used as a promotional tool.
Reference: Fundamentals of US Regulatory Affairs, Sixth Edition.

Patient Protection and Affordable Care Act (PPAC Act)

2010-07-18T22:12:00.000-07:00

Patient Protection and Affordable Care Act (PPAC Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act to create an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to or “interchangeable” with an FDA-approved biological product. These new provisions may also be referred to as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act).
The goal of the BPCI Act is similar, in concept, to that of the Drug Price Competition and Patent Term Restoration Act of 1984 (a.k.a the “Hatch-Waxman Act”) which created abbreviated pathways for the approval of drug products under Federal Food, Drug, and Cosmetic Act (FFD&C Act).
The BPCI Act aligns with the FDA’s longstanding policy of permitting appropriate reliance on what is already known about a drug, thereby saving time and resources and avoiding unnecessary duplication of human or animal testing.

To read more about this, click here.

Food Ingredients and Packaging

2010-07-11T21:12:00.000-07:00

FDA has very limited authority to regulate food before it goes on the market. A significant exception is regulation of food and color additives, which must be approved by FDA as safe for intended uses prior to marketing. Definition of “food additive” includes not just the ingredients added to the food, but also any substance used in the production process that could end up in the food, including packaging material that could leach onto food and lubricants on the machines that touches the food during processing.

FD&C Act specifically excludes the following types of substances from the definition of food additives:

Any substance that is generally recognized as safe for its intended uses by scientific experts.

Pesticide chemical residues.

Pesticides.

Color additives.

New animal drugs.

New dietary ingredients.

Prior sanction: any substance approved or sanctioned for use prior to 6 September, 1958 under the FD&C Act of 1906 or the Poultry Products Inspection Act of 1957.

Reference: Fundamentals of US Regulatory Affairs, Sixth Edition, By; Regulatory Affairs Professional Society.

RareSpace Leverages Medpedia’s Technology Platform

2010-07-05T19:49:00.000-07:00

I would like to share that on Tuesday, June 29th, Medpedia announced RareSpace, an online knowledge sharing platform for rare childhood diseases, which affect 22.5 million American families. Designed in partnership with the R.A.R.E. Project and the Children’s Rare Disease Network, RareSpace provides a platform to advance research and share information on these diseases.
Parents, physicians, researchers, advocates and others interested in rare diseases are encouraged to participate in discussions and share information about genetic diseases, innovations in research, and standards of care. Medical professionals in RareSpace will answer questions about treatment, best practices, and how to best help these children and their families. Anyone with an interest in rare diseases is invited to join at http://www.medpedia.com/communities/274-RareSpace.

The ASR (Analyte Specific Reagent) Rule

2010-06-27T20:06:00.000-07:00

As per 21 CFR 864. 4020(a), ASRs are defined as antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASRs are medical devices that are regulated by FDA. They are subject to general controls, including current Good Manufacturing Practices (cGMPs), 21 CFR Part 820, as well as the specific provisions of the ASR regulations (21 CFR 809.10(e), 809.30, 864.4020).

The guidelines set by FDA for marketing the ASRs are known as “The ASR Rules”. The rule classifies most ASRs as Class I devices subject to general controls under section 513(a)(1)(A) of the Act, but exempt from premarket notification.

To read more about the ASR Rule, follow the link.

Pediatric Research Equity Act (PREA)

2010-06-20T22:41:00.000-07:00

Pediatric Research Equity Act (Dec, 2003) requires pediatric studies of certain drugs and biological products unless waived or deferred.

The law mandates a pediatric assessment for applications with new ingredients, new indications, new dosage forms, new dosing regimens or new routes administration.
PREA also requires that the studies must be designed to pose minimal risks and direct benefit. For a course of disease or effect similar to adults, effects can be extrapolated from the studies conducted in adults.

To read more about the PREA, click here.

The Hazardous Waste Source Reduction and Management Review Act of 1989

2010-06-15T22:00:00.000-07:00

BayBiotech.NET

The Hazardous Waste Source Reduction and Management Review Act of 1989 applies to large quantity generators that produce more than 12,000 kilograms (13.2 tons) of hazardous waste, or 12 kilograms (26 pounds) of extremely hazardous waste, in 1990 and every four years thereafter. The law requires the generator companies of such hazardous waste to:
• Conduct a source reduction evaluation of their facilities and prepare the following:

 Source Reduction Evaluation Review and Plan (Plan)

 Hazardous Waste Management Performance Report (Report)

 Summary Progress Report (SPR)

• Implement feasible methods for reducing the quantity and/or the hazardous characteristics of routinely generated hazardous waste.

The main purpose of requiring generators to review and implement source reduction practices is to reduce the quantity of hazardous waste generated in California and thereby to promote public health and safety and to improve environmental quality.
Such a source reduction can also help large quantity generators to become more efficient in their use of resources.
The Plan must also include a list of potential source reduction measures for major waste streams, and describe the efforts taken to evaluate these measures. Major waste streams are defined as those waste streams that exceed five percent of the total weight of routinely generated hazardous wastes. Such major waste streams can fall under one of three categories:

• Category A: hazardous wastes that are processed through an on-site wastewater treatment unit prior to discharge to a publicly owned treatment works (POTW) or to receiving water under a National Pollution Discharge Elimination System (NPDES) permit.

• Category B: all other hazardous wastes that is not processed in a wastewater treatment unit.

• Category C: all wastes that are classified as extremely hazardous wastes.

Please click here to understand more about The Hazardous Waste Source Reduction and Management Review Act of 1989.

FDA Launches Medical Device and Radiation-Emitting Product Transparency Web Site

2010-06-08T20:58:00.000-07:00

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On April 19th, 2010 FDA launched he Center for Devices and Radiological Health (CDRH) Transparency Web site in support of the agency’s Transparency Initiative.
The Web site makes available new information about CDRH’s decision-making processes and displays this information in a more user-friendly format. The site includes new information such as basic information about medical devices and how FDA regulates those products, information about medical devices before and after the products are on the market, in a searchable database, information about the clinical studies and trials conducted to demonstrate the safety and effectiveness of certain medical devices, memos from FDA employees explaining the reasons for the agency's decisions about medical device manufacturer requests to make a significant change in components, materials, design, specification, software, color additive, and labeling of a medical device as well as a step-by-step guide for manufacturers of radiation-emitting products to assist with the regulatory process.

To read more about it, click here.

Scalable Compliance for a Biotech Start-up

2010-06-03T21:14:00.000-07:00

BayBiotech.NET
While a biotech start-up faces numerous challenges, it must give a top priority to incorporate compliance and quality standards from the beginning in day to day operations. Due to the nature of business for a biotech, it is of utmost importance to understand the regulations around the line of product and implement into the business for future audits and mitigations. A key element in developing successful regulatory strategy is to prepare a plan that is simple enough to be understood and communicated by all—the business, technical, and legal staff—who will ultimately be responsible for carrying out the plan. Apart from compliance, there are several other key points that a start-up biotech must consider and focus on to make the most of it’s intial investments for future growth.

To read more about it, follow the link: Top 10 Legal Issues Biotech Start-Ups Must Address.

Safety Reporting Portal (SRP)

2010-05-25T21:48:00.000-07:00

Food and Drug Administration (FDA) and the National Institutes of Health (NIH) l have launched a new Web site for industry to report food safety problems or adverse events involving FDA-regulated foods (except for dietary supplements and infant formula), animal feeds, and animal drugs. Consumers can also use the site to report problems with pet foods and pet treats. The new site has been launched on May 24, 2010 is called the Safety Reporting Portal (SRP) and provides greater and easier access to online reporting. You can click here to navigate through the website.

OSHA’s Efforts to Control Exposure to Infectious Agents in Health Care

2010-05-18T23:33:00.000-07:00

BayBiotech.NET

U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) is collecting information and comment on occupational exposure to infectious agents in settings where health care is provided, including hospitals, outpatient clinics, school clinics and correctional facilities, and settings such as laboratories that handle potentially infectious biological materials, medical examiner offices and mortuaries.

In order to implement safe working environment, main objective is to collect information and data on the facilities and the tasks potentially exposing workers to this risk in order to implement successful employee infection control programs.

More information on the request for information and how to submit comments is available at http://s.dol.gov/38. Comments may be submitted by Aug.4, 2010.

Personalized Medicine and Nutrition

2010-05-14T09:11:00.000-07:00

BayBiotech.NET
International efforts to complete the human genome project and HapMap (Haplotype mapping of human genome) projects channelized the development of Division of Personalized Nutrition and Medicine (DPNM). Data generated from these projects made us to think in the direction of personalized medicine emphasizing that even though humans are genetically similar, each retains a unique genetic constitution that contributes to the wide array of biochemical, physiological, and morphological phenotypes in human populations. The unique identity is mostly shaped by nutrients and environment in which an individual lives.
DPNM is geared to develop and implement research strategies that account for genetic, environmental, and cultural diversity that influence expression of genetic makeup and produce knowledge for improving personal and public health.
Within DPNM, there are two active divisions—Biometry and Biology. While, Biometry branch works to develop biometrical methods for all aspects of the FDA’s mission, goals, and objectives, the Biology branch is focusing on the broad areas of pharmacogenomics and nutrigenomics—how individuals respond to drugs and nutrients in foods.
To learn more about ongoing research projects evolving the guidelines, follow Personalized Nutrition and Medicine.

Harmonization by Doing (HBD): Japan & U.S. Collaboration

2010-05-12T20:33:00.000-07:00

BayBiotech.NET
HBD is an international cooperative effort by Japan and US for regulatory convergence for Medical Devices. The efforts are focused on to develop global clinical trials and address regulatory barriers for timely device approvals.
To address the needs for additional evaluation, the HBD initiative is a pilot project launched jointly by FDA and MHLW-PMDA for the premarket review of device cardiovascular technology.
Instead of taking a theoretical approach to harmonization, HBD is focused on Proof of concept by utilizing parallel development, application submissions and review of actual medical device projects. HBD Study intends to collect and analyze regulatory submission data from multiple applications in the U.S. and Japan.
The purpose of the study is to further understand differences that may exist with format and content, to define best practices and to improve globally harmonized processes. To read more about the HBD program, follow the link: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/InternationalInformation/ucm053067.htm

Use of International Standard ISO-10993 for Biological Evaluation of

2010-05-07T20:47:00.000-07:00

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ISO 10993 describes a set of standards for evaluating the biocompatibility of a medical device prior to a clinical study. Based on these guidelines, agency’s modified guidelines entitled "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing," describes a FDA-modified matrix that designates the type of testing needed for various medical devices.

Main criteria to consider when selecting the appropriate tests for biological evaluation of a medical device are the chemical characteristics of device materials and the nature, degree, frequency and duration of its exposure to the body. In general, the main type of tests include: acute, sub-chronic and chronic toxicity; irritation to skin, eyes and mucosal surfaces; sensitization; hemocompatibility; genotoxicity; carcinogenicity; and, effects on reproduction including developmental developmental effects.

However, depending on varying characteristics and intended use of devices as well as the nature of contact, these general tests may not be sufficient to demonstrate the safety of some specialized devices. Additional tests for specific target organ toxicity may be necessary for some devices. If a device is made of materials that have been well characterized chemically and physically in the published literature and have a long
history of safe use, for the purposes of demonstrating the substantial equivalence of such devices to other marketed products, it may not be necessary to conduct all the tests suggested in the FDA matrix of this guidance.

The detailed flowchart and matrix can be followed on the following link:
Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'

XML backbone based eCTD Documents

2010-05-05T06:35:00.000-07:00

BayBiotech.NET

The eCTD submission requires construction of XML based backbone for the submission with strict guidelines for file name size, pdf style and hypertexting format. Although the XML based backbone is a choice for submission as it gives an advantage by making the submission independent of operating system environment, but also imposes some issues for a successful submission. In order to avoid the pitfalls and delay in response of obtaining RTF (refuse-to-file) along with the expertise in preparing high quality .pdfs for submission and expertise in XML is also required.

On analyzing the various tools available in the market, my recommendation will be to use caution in using such tools without double checking the submissions and having an independent quality check of your own as such tools are still at prelim phases of development and as a sponsor you may not wish to bet your million dollar investment on a RTF.

A good quality .pdf, an accurate XML coding as well as strictly following the eSubmission guidelines will be the key to success and you as a sponsor must be ready to invest in training your staff much ahead of time to gain success in future submissions.

The link here shares the experience of a small biotech in order to make you understand the relevance of a high quality preparation for eCTD Gateway: http://www.entrepreneur.com/tradejournals/article/175407584.html

Medical Device Regulation in India

2010-04-30T11:41:00.000-07:00

BayBiotech.NET

At present, the Indian market for medical devices is largely unregulated and Medical devices can freely be imported into India. Solely, the key decision maker is either the doctor, or a private or government hospital that evaluates the device and imports it to India.

Although the FDA approved products are preferred because of their better
quality and performance, but since India is a price sensitive market, low priced, poor quality medical devices find a bigger and more favored market.

To ensure the quality of healthcare service and keeping the globalization of the clinical trials in mind, the Government of India is in the process of developing regulations for medical devices. A set of guidelines are expected to evolve that would bring a select group of medical devices under the regulatory framework.

In India, the authority regulating medical devices will be the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health. The CDSCO is the authority, which lays down rules, standards and approves import and manufacturing of drugs, diagnostics, devices, and cosmetics. Currently, CDSCO’s functions are to establish the standards and regulations for drugs, blood and blood products, intravenous fluids, and vaccines. With added responsibility of regulating the medical devices industry, CDSCO will be the approving authority for import, manufacture and sale of medical devices in India.
To read more on the topic follow the link: http://www.cdsco.nic.in

Reference:

1. http://www.trade.gov/td/health/india_med_registration05.pdf

RoHS Directive and Exemptions

2010-04-27T19:52:00.000-07:00

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RoHS (Restriction of the Use of Certain Hazardous Substances) directive bans placing the new electrical and electronic equipments on the EU market containing more than agreed levels of lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyl (PBB) and polybrominated diphenyl ether (PBDE) flame retardants. These are the regulations under EU Directive 2002/95. The RoHS Directive and the UK RoHS regulations came into force on 1 July 2006. Since then, there have been amendments about exemptions regarding the levels of abovementioned articles in certain products. In order to get the latest on the exemptions as well as to understand the directive before manufacturing your product for the European market, follow the link: http://www.rohs.gov.uk/Default.aspx.

Validation of eCTD Tools

2010-04-23T11:39:00.000-07:00

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Electronic Common Technical Document (eCTD) is an ICH standard adopted by FDA as a member of ICH, together with other member regions, Europe & Japan to facilitate electronic submissions to the agency. Harmonization of guidelines has been done to achieve global consistency in order to facilitate globalization of the drug discovery efforts. As of 2008, eCTD standard is the only acceptable format for new electronic submissions to the agency with an exceptions for submissions that are already under review. As the agency is working to standardize the eCTD process, it is encouraging the Industry to begin working on establishing a system for eCTD submissions. It is advisable to either use an in-house developed or commercially purchased e-CTD tool. In order to validate your eCTD tool, it will be important to pay attention to the following major issues identified by the agency regarding the eCTD submissions:

1. Lack of 356h, 1571, or 2252 forms in a submission.

2. Lack of .pdf Fillable Forms in a submission.

3. Usually more than one form in a submission is identified.

4. Mismatched, incorrect or missing application numbers.

6. Most of the eCTD submitted as eNDA.

7. More than one sequence included in one gateway submission.

8. One submission applied to more than one application.

9. Single file submission – Usually a single PDF file.

A validation plan to check for the abovementioned issues will help reduce the review time of a submission at the agency and will not cause a delay or return of your submission.

If you would like to read more on the eCTD submission, follow the link:
Electronic Regulatory Submission and Review (ERSR)

Orphan Drug Designation

2010-04-20T12:33:00.000-07:00

BayBiotech.NET

Orphan Drug is a special status designated to a drug or biologics to treat a rare disease or condition. In order to obtain this designation, drug or biologics must meet certain criteria.

Orphan designation qualifies the sponsor for the tax credit and marketing incentives as per Orphan Drug Act. In addition, orphan drug is not subject to a prescription drug user fee unless used for other indications.

For application purposes, sponsor shall submit two copies of a completed, dated, and signed request for designation that contains the following:

(1) A statement that the sponsor requests orphan drug designation for a rare disease or condition.

(2) The name and address of the sponsor; the name of the sponsor's primary contact person.

(3) A description of the rare disease or condition for which the drug will be investigated.

(4) A scientific rationale for the use of the drug for the rare disease or condition.

(5) Where the sponsor of an already approved orphan drug seeks orphan drug designation for the subsequent drug for the same rare disease or condition, an explanation of why the proposed variation may be clinically superior to the first drug.

(6) If a drug is under development for only a subset of persons with a particular disease or condition, a justification that the subset is medically plausible.

(7) A summary of the regulatory status and marketing history of the drug in the United States and in foreign countries.

Application must have supportive documents to demonstrate that the disease or condition for which the drug is intended affects fewer than 200,000 people.
More information about Orphan Drug Status and tips for application can be found at:
Designating an Orphan Product: Drugs and Biologics, http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/HowtoapplyforOrphanProductDesignation/default.htm

A Facility Inspection Checklist

2010-04-13T11:36:00.000-07:00

BayBiotech.NET

Whether you are a Quality Assurance/ Compliance personnel planning to make a visit for a facility inspection, this checklist will help you prepare an inspection report based on the information that might be required to collect about the facility during the inspection. This checklist may help you evolve different forms for the inspection in order to accumulate complete information about the facility:

1.General information
(a) name of establishment inspected
(b) date of inspection
(c) name(s) of the inspector(s)
(d) date of last inspection.

2.Type of inspection
Comprehensive, concise, follow-up, special, investigative, announced, and unannounced.

3.Licensing
(a) licensing of premises
(b) person with supervisory role in establishments
(c) adherence to licensing provisions.

4. Activities undertaken on premises
manufacturing, wholesale, importation, export, retail, hospital, pharmacy, clinic, nursing and maternity homes.

5. Adequacy and suitability of premises
(a) premises clean, tidy and in good state of repair
(b) premises secure
(c) floor durable and easily cleaned
(d) premises constructed to prevent infestation by vermin and pests
(e) changing rooms and toilet available
(f) adequacy of lighting and ventilation
(g) appropriate layout of premises.

6. Warehouse/store
(a) adequacy and suitability of warehouse/store
(b) warehouse/store clean and uncluttered
(c) warehouse/store inaccessible to unauthorized persons
(d) temperature and humidity control
(e) enforcement of stock rotation
(f) adequacy of shelving
(g) existence of areas for returned, recalled, quarantined or expired products
(h) warehouse/store free from vermin and insects.

7. Special storage
(a) availability of cold room storage or refrigerator for vaccines and
biological products
(b) suitability of the cold storage facilities
(c) standard written procedure prepared by an appropriate national
regulatory agency for the maintenance of cold chain
(d) special storage area for controlled drugs and other prescription drugs
(e) suitable and secure storage facility for controlled drugs and poisons.

8. Record-keeping
(a) name and address of supplier of each product with date
(b) name and address of purchaser of each product with date
(c) supplier or purchaser license
(d) retention of order forms, copy of delivery notes, stores receipt, and issue vouchers, and book of records (controlled drugs book/prescription drugs book) on the premises as provided for in the drug laws
(e) accuracy of records kept.

9. Conditions for sale and supply
(a) sale and supply of product under the control of an authorized personnel
(b) sale and supply of product from registered/licensed premises
(c) sale of prescription (drugs) on the basis of valid prescription

10. Diversion of controlled products
Diversion of controlled products prevented by examining the records and by physical examination of stock.

11. Returned and expired products
Procedures in place for handling returned and time-expired products.

12. Product recalls
Procedures in place for recall of products and handling recalled products.

13. Product complaints
Procedures in place for dealing with complaints about products.

14. Promotional activities
Assess promotional materials for compliance with laws.

15. Personnel
(a) person responsible for supervising sale in a wholesale/retail pharmacy is a registered/licensed pharmacist
(b) name of the personnel
(c) personnel wears clean protective clothing.

16. Labeling of products and package inserts
Check adequacy of labeling of products and information on package inserts.

17. Physical examination and sampling of products
Conduct physical examination of products in stock and take samples for quality assessment.

18. Reference books
Check existence of reference books on premises, where they are required.

19. Guidance on sampling
(a) Check that the sample is properly labeled with the following:
(I) name of sampled pharmaceutical preparation
(II) batch number
(III) date and source of sample; the original manufacturer's label may be helpful.

(b) Check that the records contain the following:
(I) number of samples
(II) types of packaging and storage conditions
(III) circumstances of sampling that may include suspected quality defects.

(c) Place seals on containers of the samples.
(d) Hand over one-third of the samples to the representative of the inspected establishment.
(e) Confirm in writing that samples were taken from the premises and have the confirmation countersigned by an appropriate official of the inspected establishment.

Overall it is the management's objective to manufacture the product as per the specifications and guidelines.
Records Maintenance for Equipments in Use

Records of major equipment use, cleaning, sanitization, maintenance etc should show the date, time (if appropriate), product, and batch number of each batch processed in the equipment, and the person who performed the cleaning and maintenance.

Electronic Freedom of Information Act Amendments of 1996

2010-04-09T09:41:00.000-07:00

BayBiotech.NET

The U.S. Freedom of Information Act (FOIA) is a law ensuring public access to U.S. government records. Upon written request, agencies of the United States government are required to disclose those records, unless they can be lawfully withheld from disclosure under one of nine specific exemptions in the FOIA as under:

(1) Information specifically authorized under criteria established by an Executive order to be kept secret in the interest of national defense or foreign policy.

(2) related solely to the internal personnel rules and practices of an agency;

(3) specifically exempted from disclosure by statute provided that such statute requires that the matters be withheld from the public in such a manner as to leave no discretion on the issue, or establishes particular criteria for withholding or refers to particular types of matters to be withheld;

(4) trade secrets and commercial or financial information obtained from a person.

(5) inter-agency or intra-agency memorandums or letters which would not be available by law to a party other than an agency in litigation with the agency;

(6) personnel and medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of personal privacy;

(7) records or information compiled for law enforcement purposes.

(8) contained in or related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions; or

(9) geological and geophysical information and data, including maps, concerning wells.

Below is the full text of the Freedom of Information Act in a form showing all amendments to the statute made by the "Electronic Freedom of Information Act Amendments of 1996," signed as Public Law No. 104-231, 110 Stat. 3048:

Each agency shall separately state and currently publish in the Federal Register for the guidance of the public--

(A) descriptions of its central and field organization and the established places at which, the employees (and in the case of a uniformed service, the members) from whom, and the methods whereby, the public may obtain information, make submittals or requests, or obtain decisions;

(B) statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;

(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;

(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and

(E) each amendment, revision, or repeal of the foregoing.

Each agency, in accordance with published rules, shall make available for public inspection and copying--

(A) final opinions, including concurring and dissenting opinions, as well as orders, made in the adjudication of cases;

(B) those statements of policy and interpretations which have been adopted by the agency and are not published in the Federal Register;

(C) administrative staff manuals and instructions to staff that affect a member of the public;

(D) copies of all records, regardless of form or format, which have been released to any person under paragraph (3) and which, because of the nature of their subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records; and

(E) a general index of the records.

In making any record available to a person under this paragraph, an agency shall provide the record in any form or format requested by the person if the record is readily reproducible by the agency in that form or format. In responding to a request for records, an agency shall make reasonable efforts to search for the records in electronic form or format, except when such efforts would significantly interfere with the operation of the agency's automated information system.
The amount of information deleted shall be indicated on the released portion of the record, unless including that indication would harm an interest protected by the exemption in this subsection under which the deletion is made.

In addition, on or before February 1 of each year, each agency shall submit to the Attorney General of the United States a report which shall cover the preceding fiscal year and include the details of number of public requests, denials and the reasons for the denials by the agency for a not providing the information to the public. It must also notify the median number of days taken by the agency to process the requests as well as the number of full-time staff of the agency devoted to processing requests.

To read more about the Freedom Of Information Act and Electronic Freedom of Information Act Amendment 1996 follow the link: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

Available Total Quality Management Tools

2010-04-07T21:34:00.000-07:00

BayBiotech.NET

Total Quality Management (or TQM) is a management concept coined by W. Edwards Deming. One of the principal aims of TQM is to limit errors to 1 per 1 million units produced. There are several TQM tools available today to analyze and assess qualitative and quantitative data. These tools can be examined and used to enhance the overall quality of the procedures, products or the work environment.

Some of the most common TQM tools in use today are Pie Charts and Bar Graphs, Histograms, Run charts, Pareto Charts, Force Field Analysis, Ishikawa or Fishbone Diagrams, Tree Diagrams, Brainstorming, Flow Charts, Plan-Do-Check-Act cycle and Scatter Diagrams.

Proper integration and use of these tools ultimately assist in processing data such as identifying collecting policies, enhancing work flows, ensuring client satisfaction by surveying their needs and analyzing them accordingly and creating an overall high level of quality in all areas of your organization. Use and choice of various tools remain flexible within an organization. To read more about the Total Quality Management Tools, follow the links as under:

1.http://www.slais.ubc.ca/people/students/resumes/C_Payne/media_pdf/TQMTools.pdf
2.http://en.wikipedia.org/wiki/Total_quality_management
3.http://www.bexcellence.org/Total-Quality-Management-Tools.html

New ISO Guidelines for Protecting Electronic Health Records

2010-04-02T07:03:00.000-07:00

BayBiotech.NET

Two ISO documents recently published provide harmonized principles and guidelines for the security of electronic health records.

ISO/TS 21547:2010, Health informatics – Security requirements for archiving of electronic health records – Principles covers the basic principles needed to securely preserve health records in any format for the long-term. In the document, a holistic process covering records maintenance, retention, disclosure and eventual destruction has been extensively covered.

Additional guidance for implementing ISO/TS 21547 is included in technical report ISO/TR 21548:2010, Health informatics – Security requirements for archiving of electronic health records – Guidelines. This report provides complementary guidelines to ISO/TS 21547, as well as a practical method and tools for the development and management of eArchives.

Main features include the retention and records maintenance for a patient for entire lifespan reaching to 100+ years regardless of time and place. The two ISO documents also take into account the dynamic nature of health data, which may be modified through time, its sensitivity and high security requirements, particularly as transferred between services organizations and healthcare providers, and more.

In addition, the two ISO documents also take into consideration new initiatives in the field, such as the growing trend to reinforce patients’ self determination and participation in their own healthcare, and the data that must be available to them.

The two documents were developed by ISO technical committee ISO/TC 215, Health informatics and to find out more on this follow the link: http://www.iso.org/iso/pressrelease.htm?refid=Ref1304

Essentials of an Effective SOP

2010-03-31T11:30:00.000-07:00

BayBiotech.NET

Standard Operating Procedures (SOP) are valuable tool that go beyond the basic procedural description of materials and methods and provide details about the appropriate precautions. A well written SOP is always a binding document in a regulatory environment and defines the details of the procedure to be followed across the board within an organization to perform a specific procedure.

A well written SOP for a particular procedure should evolve with time after repeating the process under Research and Development Unit by testing the feasibility of the steps that makes it an easy to follow methods and minimizes the risks for Out of Specification reporting later on. A well evolved SOP has its origin from a simple stepwise flow chart of a complete process. If any changes are made in the process the SOP version in use must be updated by approval of the appropriate authorities and must be brought in use and supersede any other previous versions.

A typical SOP contains the following elements:

A Header which shows the Title of the SOP, Original Issue Date, Revision/Review Date, number of pages contained in the SOP, who wrote the SOP, and the Approval Signature.

• purpose and scope
• definitions
• materials and equipment needed
• safety concerns,
• who is responsible
• step-by step procedure with identification and emphasis of "critical steps"
• records to be kept
• copies of forms to be used
• References.
SOPs should be reviewed annually at a minimum.

“A well written SOP must have some room for flexibility and ensure that the procedure is compliant with the laws and regulations that you have to support for the purpose of your work.”

References: 1.SOPs: A must for sites, Appl Clin Trials, March 2010.
2. The SOP, http://www.hawaii.edu/ehso/bio/theSOP.htm

Quality of Harmonized Drug Substance Dossier for a Marketing Authorization

2010-03-26T17:09:00.000-07:00

BayBiotech.NET

Through the ICH process (ICH M4Q), considerable harmonization has been achieved among the three regions (Japan, EU and US) in the technical requirements for the registration of pharmaceuticals for human use. To avoid the need to generate and compile different registration dossiers, the ICH: M4 guideline describes a format for the Common Technical Document that will be acceptable in all three regions.

In a nutshell, CTD is an internationally agreed upon format for the preparation of a presentation for applications to be submitted to the regulatory authorities. However, the CTD does not address the content of submissions. There are many regional requirements, as well as applicants’ preferences, that could affect the contents of dossiers submitted in each region.

According to the ICH guidelines, a document is defined for a paper submission as a set of pages, numbered sequentially and divided from other documents by a tab and a document can be equated to a file for an electronic submission. In an electronic submission, a new file starts at the same point at which in a paper submission, a tab divides the documents.
In deciding whether one or more documents or files are appropriate, it should be considered that once a particular approach has been adopted, the same approach should be used throughout the life of the dossier since it is the intention that replacement documents/files be provided when information is changed.

It is recommended that all the text and tables should be prepared using margins that allow the document to be printed on A4 paper (EU and Japan) and 8.5x11” paper (USA). Times New Roman, 12-point font is recommended for narrative text.

For more details follow the link: ICH M4Q Guideline Common Technical Document for the Registration of Pharmaceuticals for Human use, Quality

ISO 22000: Food Safety Management System (FSMS)

2010-03-23T21:31:00.000-07:00

BayBiotech.NET

ISO 22000 is a food safety management system standard that defines a set of general food safety requirements that apply to all organizations involved directly or indirectly in the food chain. ISO 22000 requires establishing a food safety management system (FSMS) to ensure that food products do not cause adverse human health effects.
ISO 22000 is designed to be used for certification (registration) purposes. However, the certification is not required. This includes every step from initial production to final consumption. More precisely, it includes the production, processing, distribution, storage, and handling of all food and food ingredients.
Main objectives of ISO 22000 is to plan, implement and establish a food safety management system in order to ensure that products do not cause adverse health effects by demonstrating compliance with legal safety requirements.
ISO 22000 uses almost the same basic structure as the ISO 9001 hence the organizations that have implemented ISO 9001 have an easier understanding of ISO 22000 planning and implementation.
References: 1. http://www.iso.org/iso/catalogue_detail?csnumber=35466
2. http://www.praxiom.com/iso-22000-intro.htm

IRBs in Developing Countries

2010-03-19T16:29:00.000-07:00

BayBiotech.NET
Conducting clinical trials in developing countries usually are faced with several local challenges and one of them is lack of local Institutional Review Board (IRBs) to review the informed consents and study protocols as well as monitor the study. Mostly, if a clinical trial is initiated outside US, the IRB within United States guides the trial. Mostly, in developing countries maintaining an efficient IRB is considered an extra financial burden on the system. Thus, a US sponsor in a developing country may face the challenges as the views on the judgment about risks and benefits of a trial may differ between the countries. In addition, developing informed consents become a main barrier due to a low literacy rate.
Thus, the best solution to this could be that two IRB committees oversee the work, one based in United States as well as one in the developing country. The US sponsor must ensure the existence of such an IRB in the country of interest. The IRB in the country of interest may have a US member who must have either loved or worked in the country and understand the local issues around specific disease or population. This will help in developing appropriate level of informed consents as well as study protocols.
Sufficient efforts must be in place to improve the competency of IRB committees in developing countries as well as the advice of the IRB committees in developing countries should be respected. Follow the link http://johnmm.bol.ucla.edu/irbReview.htm# to read more on this.

Useful Resources for Clinical Research

2010-03-17T09:20:00.000-07:00

BayBiotech.NET
Hello All,

Here is a list of some resources related to Clinical Research and Regulatory Affairs, hope you will find them useful for your work! More to follow in my next blog….

Useful Resources

1. Directory of pharmaceutical industry-funded clinical trials, free and easy-to-use interface for patients and health professionals alike to ongoing clinical trials, clinical trial results and complementary information on related issues.
Link: http://www.ifpma.org/clinicaltrials

2. Registry of federally and privately supported clinical trials conducted in the United States and around the world.
Link: http://www.clinicaltrials.gov

3. Opportunities for public involvement in clinical research: People in Research helps members of the public make contact with organizations that want to actively involve them in clinical research.
Link: http://www.peopleinresearch.org

4. Regulatory Affairs Professional Society: society of professionals engaged in regulatory affairs.
Link: http://www.raps.org

5. National Institute of Child Health and Health Development: resource for clinical research related information.
Link: http://www.nichd.nih.gov/health/clinicalresearch/

6. Council For International Organizations Of Medical Sciences
Link: http://www.cioms.ch/index.html

7. FDA Good Clinical Practices: details on regulations around Good Clinical Practices as per FDA guidelines.

Link: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm

8. International Organization of Standardization
Link: http://www.iso.org/iso/home.htm

9. International Conference on Harmonization
Link: http://www.ich.org/cache/compo/276-254-1.html

10. UK Clinical Research Collaboration: a partnership of organizations working to transform the environment for clinical research in the UK.
Link: http://www.ukcrc.org

11. UK Clinical Research Network: The UK Clinical Research Network (UKCRN) supports clinical research and helps to deliver clinical trials and other well designed studies across the UK.
Link: http://www.ukcrn.org.uk

12. Medical Research Council: Medical Research Council (MRC) has been conducting clinical trials to address important public health questions and improve clinical care.
Link: http://www.mrc.ac.uk

Efficient Laboratory Workflow Management

2010-03-12T17:33:00.000-08:00

BayBiotech.NET

In current times demands on laboratory performance are becoming more intensive as the number of new tests and diseases are adding on to our list as well as a greater demand for accuracy in test results is increasing by a much more controlled regulatory environment.
In order to meet these demands, laboratory personnel are working on an ongoing basis to improve efficiency and productivity through better control over the operation and function of all aspects of the testing process by incorporating automation and use of computerized system wherever possible.

Creation of an efficient Workflow helps make the entire process cost effective and efficient and a framework for creating a workflow may include:
1. Understanding the issues relating to creating a work list
2. Describe ways to minimize laboratory contamination
3. Understand ways to improve labor efficiency
4. Understand key variables that contribute to testing accuracy
 Explain the importance of sensitivity and specificity
 Describe the relationship between prevalence and predictive value

The core of a good laboratory set-up must focus on providing the practitioner with accurate test results that can be achieved by minimizing the cross-contamination and avoiding loss of in-process test samples at different steps of the test performed.

Two main types of cross-contamination that can occur in a laboratory set-up are:

 Organism contamination from the original sample
 Amplicon contamination, which can occur when aerosols from the amplified product enter the air and ultimately transfer to other sample tubes. Trace amounts of amplicon can initiate additional amplification reactions, potentially leading to false-positive results

Benefits of Automation:

In order to minimize the errors and maximize the accuracy of a test result organizations are implementing automations and the benefits of it include:
 Efficiency gains
 Improved turnaround time (TAT)
 Reduction in laboratory errors
 Overall improvement in patient care

In order to avoid the cross-contamination, the Laboratory design considerations may include:

1. A secluded area for sample preparation. Identify key variables that affect specimen collection and transport.
2. Describe the steps in a sample collection procedure.
3. Define carry-over contamination and describe methods to prevent its occurrence.
4. Describe methods for minimizing sample inhibition.
5. Identify sample preparation procedures that increase the risk of contamination.

In order to avoid the cross-contamination, the laboratory routine process may include:

 Avoiding moving freshly filled pipettes tips over open tubes.
 Use pipette tips that have aerosol plugs.
 Maintain physical separation between preamplified materials and amplified.
 Incorporate barriers such as oil or covers in the amplification reaction mix.
 Follow manufacturer's procedures for daily cleaning and decontamination.
 Identify sources of physical contamination, such as frequent touch-points on workstations, keyboards, telephones, etc.
 Change gloves frequently.
 Change lab coats frequently or utilize disposable gowns.
 Restrict gowns and equipment to single areas.
 Perform laboratory environmental "swipe" tests routinely to check for contamination.
Implement routine monitoring of technologist procedures to ensure strict compliance. To read more on this visit:

http://www.lab-education.org/review_ed_mod/mod01_slide38.htm

eCTD Submission Specifications

2010-03-10T10:05:00.000-08:00

BayBiotech.NET
The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. eCTD technical document format development was done by International Conference on Harmonization (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). Details on the specification for the ICH eCTD can be found in the guidance document M2 eCTD: Electronic Common Technical Document Specification. Currently, eCTD is the preferred format for electronic submissions by U.S. Food and Drug Administration.

Although originally the CTD and the eCTD were designed for marketing applications, they could apply equally to other submission types, including INDs, master files, advertising material, and promotional labeling.

In June 2008, FDA has issued guidelines for organizing the electronic regulatory document filing using the eCTD tools. This guidance discusses issues related to the electronic submission of applications for human pharmaceutical products and related submissions, including abbreviated new drug applications (ANDAs), biologics license applications (BLAs), investigational new drug applications (INDs), new drug application (NDAs), master files (e.g., drug master files), advertising material, and promotional labeling. At this time, this does not include applications supporting combination products.

As per guidance, since a document is a collection of information that includes forms, reports, and datasets, it is recommended that when making an electronic submission, each document should be provided as a separate file.

Five Modules:

Any type of document, whether a marketing application, an investigational application, or a related submission should be organized in five modules in the CTD: module 1 includes administrative information and prescribing information, module 2 includes CTD summary documents, module 3 includes information on quality, module 4 includes the nonclinical study reports, and module 5 includes the clinical study reports.

Comprehensive Table of Contents Headings and Hierarchy:

The organization of the documents making the submission must follow the “Comprehensive Table of Contents Headings and Hierarchy”. If any other headings are required a prior communication must be established with the agency before the submission. Any file submitted that does not fall into any of the categories in the Comprehensive Table of Contents Headings and Hierarchy may not be reviewed.

eCTD Backbone Files:

Once a specific application in electronic format based on this guidance is done the subsequent submissions to the application, including amendments and supplements, should include eCTD backbone files reference. One can include the information by reference by providing in the text of the document (1) the application or master file number, (2) the date of submission (e.g., letter date), (3) the document name, and (4) the page number of the referenced document along with a hypertext link to the location of the information.

Scanned vs. Text-based Documents:

Scanned documents submitted electronically as images are not as useful for review as documents that are text based. Image-based documents are more difficult to read and cannot be electronically searched. Since it takes longer to print image-based documents, and they occupy more storage space than text-based documents as far as possible text-based documents may be submitted.

Naming Electronic Files:

To function properly, the eCTD backbone files must have specific names (e.g., index.xml, us-regional.xml). For other files without a specified name, a name that is indicative of the contents (e.g., protocol-101) should be provided. However, the file name should be less than or equal to 64 characters including the appropriate file extension. Only lower case letters, numbers, or hyphens should be used in the name. Blank spaces are not recommended. When naming files, it is important to remember that — to avoid truncation — the length of the entire path of the file should not exceed 230 characters.

Naming Folders:

The main submission, regional administrative folders, and certain subfolders should have specific names for proper and efficient processing of the submission.

Recommended File Formats:

The following file formats are recommended for the use:
• PDF for reports and forms
• SAS XPORT (version 5) transport files (XPT) for datasets
• ASCII text files (e.g., SAS program files, NONMEM control files) using txt for the file extension
• XML for documents, data, and document information files
• Style sheets (XSL) and document type definition (DTD) for the XML document information files
• Microsoft Word for draft labeling (because Microsoft Word can change, check our Web site for the current version)

More details can be found at:

1. Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications,http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM072349.pdf

2. The eCTD Backbone File Specification for Study Tagging Files, http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM163560.pdf

Cold Chain Management: Good Practices

2010-03-05T20:20:00.000-08:00

BayBiotech.NET

Cold chain management is a temperature-controlled supply chain management to insure an unbroken and uninterrupted series of storage and distribution activities which maintain a given temperature range.

Cold chain management is used to extend the shelf life as well as to protect the temperature sensitive products such as fresh produce, photographic films, meat products and medicinal products from damages caused due to inappropriate temperature regulations during processing, delivery and storage.

Food industry uses the process of Hazard Analysis and Critical Control Point (HACCP), as a useful tool, however, its usage continues into other fields such as Pharmaceutical Industry. HACCP process identifies key action points known as Critical Control Points that are used to lower the hazardous risks.

HACCP is based on seven principles. The seven principles are: (1) hazard analysis, (2) critical control point identification, (3) establishment of critical limits, (4) monitoring procedures, (5) corrective actions, (6) record keeping, and (7) verification procedures. (http://www.fsis.usda.gov/OA/background/keyhaccp.htm)

ISO 22000 is based on the seven HACCP principles which is a complete food safety management system incorporating the elements of prerequisite programmes for food safety, HACCP and quality management system . Within United States, HACCP compliance is regulated by 21 CFR parts 120 and 123.

To read more about Good Cold Chain Management Practices follow the link: http://www.carrymed.com/site/alcms/file/Rafik_Bishara.PDF

European Medicines Agency : no longer ‘the EMEA’ – and not ‘the EMA’ either

2010-03-03T10:24:00.000-08:00

BayBiotech.NET

European Medicines Agency is in the process of changing its acronym from EMEA to EMA based on the feedback from the stakeholders over the past years who had questioned the existence of the second ‘e’ in the acronym which does not accurately reflect the full name. In addition, since EMEA is most frequently used in the business community to mean Europe, Middle East and Africa , European Medicine Agency has decided not to use EMEA to avoid the confusions.

Since the inception, the adaptability of the acronym EMA is still to be validated and hence the agency decides to be using its full name as European Medicines Agency or the ‘Agency’ for short in the communications with e-mail ids being exceptions where ema will be used.

The press release from EMEA has the details of all the recent changes that the Agency has undergone and is in the process of implementaion.

Rest to follow…

Assignment and Request for Agency Component Designation for Premarket Applications (21CFR Part 3.1-3.10)

2010-02-24T06:55:00.000-08:00

BayBiotech.NET
The main purpose of 21 CFR Part 3 is to support the efficiency of agency management and operations by providing guidelines for determining the agency component that will have primary jurisdiction for any drug, device, or biological product or providing the guidelines for the agency component determination where such jurisdiction is unclear. Out of 10 sections of the 21CFR Part 3 (Product Jurisdiction), the blog has the main emphasis on Sec 3.5 and 3.7 that relates to the guidance documents for agency designations as well as the requirements for request of agency designation in case the designation is unclear as per the guidance.
As per Sec 3.5, The Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Drug Evaluation and Research have developed guidance documents clarifying product jurisdictional issues. The guidance documents entitled "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health;" "Intercenter Agreement Between the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research;" "Intercenter Agreement Between the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research." are available in the Division of Dockets Management (HFA-305), Food and Drug Administration. These guidance documents describe the responsibility for categories of products or specific products.
The sponsor of a premarket application filing for a combination or other product covered by these guidance documents may contact the designated agency component identified in the intercenter agreement before submitting an application of premarket review or to confirm coverage and to discuss the application process.
For a combination product not covered by the guidance document or for a product where the agency component with primary jurisdiction is unclear or in dispute, the sponsor of an application for premarket review should follow the procedures described in Sec 3.7 to request a designation of the agency component with primary jurisdiction before submitting the premarket application.

For filing the designation request, an original and two copies of the request for designation are required with a page limit of 15 pages, including attachments, and must have the detailed identity of the sponsor and the product. If any component of the product has already received the premarket approval the Identification of such a component must be included in the designation request letter.
In the request for designation, the sponsor's are encouraged to provide with the recommendation as to which agency should have primary jurisdiction based on the mode of action that provides the most important therapeutic action of the combination product. If the sponsor is unable to determine, then the recommendation must be based on the assignment algorithm provided in section 3.4(b).
For further details about the Product Jurisdiction follow the link. Rest will follow….

Compliance for Imports of Human Drugs and Biologics

2010-02-19T20:24:00.000-08:00

BayBiotech.NET
Interstate shipment(which includes importation and exportation) of unapproved new drugs is prohibited by the Federal Food, Drug, and Cosmetic Act.Clearly, the drugs that lack approval if imported either for personal use or otherwise,violates the Act.In this context,the definition of unapproved new drugs include any drugs--including foreign-made versions of U.S. approved drugs--that have not been manufactured in accordance with FDA approval.

Imported products regulated by the FDA are inspected at the time of entry by the U.S. Bureau of Customs & Border Protection (Customs) and the shipments that are not found to comply with the law must be either brought into compliance, destroyed, or re-exported.

The importation and exportation of controlled substances requires compliance with provisions enforced by the U.S. Drug Enforcement Administration (DEA). Further information on compliance can be obtained at the DEA Office of Diversion Control website.

A draft guidance on current agency policy regarding drugs marketed in the US that lack required FDA approval can be read by clicking here.

Compliance Requirements for Stem Cell Trials

2010-02-17T08:08:00.000-08:00

BayBiotech.NET

Stem Cell Therapy although holds promises for the treatment of many diseases, this is an area not much explored yet and many countries worldwide are drafting the guidelines for conducting safer clinical trials. Therefore, it is accepted widely that prior to conducting clinical trials with stem cells a stronger than usual proof of concept may be required for the safety and efficacy of the therapy.

One of the major concerns is the rapid cell division cycles of such cells that may lead to tumor generation. Thus, it is recommended that the dose of administered cells to humans must be well adjusted to below the minimum number of cells observed to form tumors in animal models.
Due to many unanswered questions regarding the safe use of stem cells a long-term follow-ups and Biovigilance must be planned carefully before starting a trial.

In October, 2009,Center for Biologics Evaluation and Research (CBER), FDA, has issued a draft guidance to potential sponsors (cord blood banks, or registries, and individual physicians serving as sponsor-investigators) to assist in the submission of an investigational new drug application (IND) for certain unlicensed (not in accordance with 21CFR 601) hematopoietic progenitor cells, cord (HPC-C), that are needed for treatment of a patient with a serious or life-threatening disease or condition and there is no satisfactory alternative treatment.

The draft guidance is available at the following link: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM187146.pdf

Sponsors are encouraged to send in IND and BLA (Biological License Applications) as soon as possible to allow sufficient time for review, comment, and resubmission as needed to complete all actions by the end of this 2 yr period.

Since the cell/ gene therapies are emerging prime areas, a worldwide effort is ongoing for prospective harmonization and convergence of regulatory approaches. Several countries within European Commission as well as other part of the world are working closely via exchange of guidelines to evolve successful strategies for acceptance and harmonization of such therapies.

A world wide map on stem cell guidelines is available at: http://www.mbbnet.umn.edu/scmap.html.

Pre-market Quality/Regulatory Strategies in Drug/Device Development

2010-02-12T14:47:00.001-08:00

BayBiotech.NET
A well planned regulatory strategy in the initial phase of product development is an essential component to safely and effectively launch the FDA regulated product in the market. However, preparing an effective strategy leading to commercialization of the product depends on many factors and one of the most important factor is to determine the class and subcategory of the product to be developed.

For example if you plan to develop a drug, then must subcategorize it as over-the-counter, new drug, generic drug etc. Once the class and subcategory is identified, then local, state, federal and international guidelines must be reviewed thoroughly for understanding the regulatory needs for the particular class and subcategory of the product. Next step followed will be to prepare a risk/ benefit analysis and targeted pre-clinical experiments to demonstrate the safety and efficacy of the product as well as developing different protocols for procurement, experimental procedures and identifying resources for the quality supplies.

It is the responsibility of the Quality Assurance and Regulatory personnel to ensure that all the protocols and procedures in the development stages are prepared as per GLP and GMP guidelines. It is also the responsibility of the QA/RA personnel to keep the higher management informed about the compliance issues and ensure to work with them to rectify the problem areas for a smooth future marketing of the product.

Group C (Treatment IND) Drugs

2010-02-09T22:05:00.000-08:00

BayBiotech.NET

Since 1976, National Cancer Institute (NCI) in agreement with FDA has established the Group C classification system to allow access to certain drugs for the cancer patients specifically falling under a category that adequate alternative therapy or if the available alternative therapy has significant toxic effects. Each Group C drug protocol specifies patient eligibility and drug use information.

Group C drugs are provided only to properly trained physicians who have registered themselves with NCI using a special form to assure that their patient qualifies under guidelines - or protocols - for the drug. Physicians using drugs under Group C have no reporting requirements to the NCI other than the obligation to report adverse drug reactions. Group C drugs are provided free of charge, and the Centers for Medicare and Medicaid Services provides coverage for care associated with Group C therapy.

Making Group C drugs available to the critically ill patients not only provides them when they need it the most but also allows NCI to gather information about safety and activity of the drug prior to the final FDA approval.

For active investigational agents not meeting the criteria for Group C, the NCI may still provide drugs on a compassionate basis to requesting physicians for patients whose best medical interests require them. These decisions are made on a case-by-case basis, often after discussion between the requesting physician and the NCI staff.

To find out more about Group C drugs click here.

A New Clinical Trial Platform

2010-02-05T10:04:00.000-08:00

BayBiotech.NET
The Medpedia Project has established a platform ‘Medpedia Clinical Trials’ for patients, researchers and physicians to receive information about the thousands of clinical trials that are in process or about to begin worldwide. The information on various clinical trials is updated regularly from ClinicalTrials.gov and can be searched using different attributes with basic and advanced search functionalities.

Medpedia Clinical Trials platform allows visitors to leave their comments, thoughts and views on a specific clinical trial page. Most importantly, a personalized feed can also be obtained if someone is interested in learning more about on-going or about to start clinical trials on a particular condition worldwide.

Moreover, if you are reading a Medpedia article on a particular clinical condition, the information on the related clinical trials are fed automatically alongside the article page. To learn more about it visit http://www.medpedia.com/clinical-trials.

What goes into the Investigator’s Brochure?

2010-02-02T22:20:00.000-08:00

BayBiotech.NET
As per ICH guidelines, the overall aim of an Investigator’s Brochure is to provide the investigator with a clear understanding of the possible risks and adverse reactions, and of specific tests, observations and precautions that may be needed to conduct a clinical trial maintaining the safety of the patients enrolled for the study. This information must be based on scientific data produced by performed physical, chemical, pharmaceutical, pharmacological, toxicological, and clinical information of the investigational drug or device. Based on the scientific studies, the Investigator’s Brochure is intended to provide the Investigator with necessary management of study subjects throughout the clinical trial. Main focus must be given to the following measures:
A. Dose
B. Frequency of the dose
C. Method of administration
D. Safety monitoring procedures
E. List of abbreviations and acronyms
F. Description of the formulation of the drug
G. Instructions for the storage

Reference:
ICH Topic E 6 (R1) Guideline for Good Clinical Practice

Amendments for High Risk Device Type Regulatory Pathway

2010-01-29T16:59:00.000-08:00

BayBiotech.NET
Government Accounting Office (“GAO”) has issued a long-awaited report evaluating the use of the 510(k) process by the Food and Drug Administration (“FDA” or the “Agency”) in the January of 2009. Report mainly focused on Preamendment class III devices.

Although most high-risk class III medical devices are subject to the demanding premarket approval (“PMA”) process, preamendment class III devices may be cleared through the 510(k) pathway until FDA issues regulations requiring a PMA. Under the Safe Medical Devices Act of 1990, FDA was required either to reclassify preamendment class III devices into class I or II, or (2) issue regulations requiring PMA approval for the devices, GAO noted that 20 preamendment class III device types have not yet been addressed by the Agency.

GAO has urged FDA to take required steps to address the remaining class III devices that continue to be eligible for 510(k) review.

As a result of the report, FDA has committed to address all remaining preamendment class III devices for which 510(k) review is currently permitted. These devices will be reclassified either into class I or class II, or PMA submissions will be required.

Thus, going forward, companies that currently market 510(k) cleared class III devices may be required to file PMA submissions, if FDA determines that their products should remain in class III.

Reference:
United States Government Accountability Office, Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process, January 15, 2009, available athttp://www.gao.gov/new.items/d09190.pdf (GAO report).

Summary Technical Document (STED) Pilot Program

2010-01-26T22:06:00.000-08:00

BayBiotech.NET
STED is a harmonized submission format for regulatory submissions developed by the Global Harmonization Task Force (GHTF).

GHTF is a voluntary partnership of government and industry representatives from the United States and four other member states: Australia, Canada, the European Union, and Japan. Main objective of the GHTF is to promote international harmonization of medical device regulation through the preparation and distribution of guidelines such as the proposed STED format.

CDRH has implemented a voluntary pilot premarket review program intended to assess the feasibility of the STED format and content for certain PMA applications and 510(k) submissions and encourages medical device manufacturers to participate in the STED Pilot Program. The participation in the program will benefit the manufacturers especially those seeking international regulatory approval/clearance for their devices.

To find out more about the program as well as the eligibility of your device click on STED.

Levels of Containment against a Biohazardous Agent

2010-01-22T19:03:00.000-08:00

BayBiotech.NET
As per definition of Office of Health and Safety, “containment" is a term used for describing safe methods for managing infectious materials in the laboratory environment where they are being handled or maintained.
The main objective of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous agents.
Two levels of containment defined are Primary and Secondary containment. Whereas, primary containment refers to the protection of personnel and the immediate laboratory environment from the infectious agents, the secondary containment refers to the protection of the environment external to the laboratory from the exposure to the infectious agent/ material.
Primary containment is provided by good microbiological techniques and use of appropriate safety equipments. Secondary containment is provided mainly by a combination of facility design and operational procedures.
A combination of risk assessment for a specific infectious agent, good practices, use of safety equipments and facility design will provide appropriate containment.
More on this topic can be read at CDC site.

Reauthorized Medical Device User Fees for FY 2008 - 2012

2010-01-19T16:45:00.000-08:00

The legislation on the Medical Device User Fee Amendments of 2007 (MDUFA), is part of a larger bill — the Food and Drug Administration Amendments Act of 2007 (H.R. 3850) and according to this, a substantial reduction for all existing application fees have been proposed, while providing for new types of medical device user fees.
The new user fees are proposed for:
• Submission of a 30-day notice.
• Submission of a 513(g) request for classification information.
• An annual fee for periodic reporting on a class III device.
• An annual fee for the registration of a medical device establishment that is a manufacturer, a single-use device reprocessor, or a specification developer.
On the other hand all existing application fees are substantially reduced for PMA, Panel-track PMA Supplement, BLA Efficacy Supplement, as well as 510(k) Notification remarkably for small businesses in a range between -18 – 70%.

Follow this link to read more on this:
Medical Device User Fees Have Been Reauthorized for Fiscal Years 2008 - 2012

BayBiotech.NET

510(k) Summary or Statement

2010-01-15T11:50:00.000-08:00

BayBiotech.NET
A premarket notification from a manufacturer must include either a summary of the 510(k) safety and effectiveness information of the product upon which the substantial-equivalence determination is based or a statement that this information will be made available by the 510(k) applicant to any person within 30 days of a written request.

As per FDA definition, these are the definition of Summary and Statements:

Summaries are released by FDA regarding a 510(k) clearance when requested under the Freedom of Information (FOI) Act whereas Statements are used to arrange for this FOI request to be fulfilled by the 510(k) applicant.

510(k) Summaries: If a summary is included, it must be submitted with the 510(k) notification as per FDA guidelines. The summary must be complete and correct in order for FDA to complete its review of a 510(k) submission. FDA will accept summaries and amendments until it issues a determination of substantial equivalence. If a summary has been submitted, requests for copies of it are legally supposed to be furnished by FDA through the FOI process within 30 days after determining that the device is substantially equivalent to another device. A complete information about the essential components of a Summary can be found on FDA’s website.

510(k) Statements: If a 510(k) submitter chooses instead to provide a 510(k) statement, it must be on a separate letterhead page, clearly identified as "510(k) Statement," and signed by the certifier.
Written requests by any individual for a copy of the 510(k) must be fulfilled by the statement certifier within 30 days of receipt of the request. Only patient identifiers, trade secrets, and confidential commercial information may be purged from the statement. Those submitting 510(k) applications are not permitted to charge requesters for compiling and disseminating these data.

To read more about the 510(k) filing visit DeviceLink.

Use of Protected Health Information

2010-01-12T13:13:00.000-08:00

BayBiotech.NET
Protected Health Information or individually identifiable health information relates to the data about demographics, individual’s past, present or future physical or mental health or condition, provision of health care to the individual, or the past, present, or future payment for the provision of health care to the individual. Individually identifiable health information includes many common identifiers such as name, address, birth date and social security number.

A covered entity (health plan, a health care clearinghouse, or a health care provider) must obtain the individual’s written authorization for any use or disclosure of protected health information that is not for treatment, payment or health care operations or otherwise permitted or required by the Privacy Rule.

Principle of “Minimum Necessary” Use and Disclosure

Principle of “Minimum Necessary” is the central aspect of the privacy rule. Under this principle, it is expected that a reasonable effort must be made to use, disclose, and request only the minimum amount of protected health information needed to accomplish the intended purpose.

However, the minimum necessary standard does not apply to the following:
1.Disclosures to or requests by a health care provider for treatment purposes.
2.Disclosures to the individual who is the subject of the information.
3.Uses or disclosures made pursuant to an individual’s authorization.
4.Uses or disclosures required for compliance with the Health Insurance Portability and Accountability Act (HIPAA) Administrative Simplification Rules.
5.Disclosures to the Department of Health and Human Services (HHS) when disclosure of information is required under the Privacy Rule for enforcement purposes.
6.Uses or disclosures that are required by other law.

For more information, follow the link: Protection of Human Subjects

Quality Assurance and Compliance: Requirements for Batch Production Records

2010-01-08T22:13:00.000-08:00

Quality Assurance and Compliance: Requirements for Batch Production Records

BayBiotech.NET

Requirements for Batch Production Records

2010-01-08T22:10:00.000-08:00

BayBiotech.NET
Batch Production Record is an example of a GMP document and is designed to standardize the process and provides with lot-specific information.
GMP Requirements for Batch Records are defined under following FDA regulations:
 Master Batch Record 21 CFR 211.188
 21 CFR 211.194—Laboratory Records
 21 CFR 211.194—Review by the Quality Control Unit
A batch production record must be established every time a batch is manufactured and must include the following:
Requirements for Laboratory Operations

•Establish and follow written procedures for laboratory operations
•Use adequate laboratory facilities
•Requirements for Laboratory control processes
•Methods for testing and examination
Requirements for Manufacturing Operations
•Establish and follow written procedures for manufacturing operations
•Ensure product specifications are consistent
•Adequate sanitation principles
•Prevent contamination
•Appropriate disposition of rejected or unsuitable dietary supplements
•Requirements for repackaging and relabeling
•Packaged and labeled supplements rejected for distribution
•Record Keeping
•Establish and follow written procedures for holding and distributing operations
•Requirements to hold components, supplements, packaging and labels
•Requirements for in-process materials
•Requirements for reserve samples
•Distribution requirements to protect against contamination and deterioration

The content produced here are part of the QA/Regulatory training taken from Kriger Research Center.

Main Components of an Informed Consent

2010-01-05T11:54:00.000-08:00

BayBiotech.NET
Dear All,

Happy 2010!

I plan to focus on the main components of an informed consent in this blog. Enjoy!

Informed consent (21 CFR 50.20, 21 CFR 50.25(a), and 21 CFR 50.25(b))
is a document prepared for the subjects who may be benefited from a clinical trial and provides the key facts about a clinical trial before deciding whether or not to participate.
In order to help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided for them.
Main component of an informed consent document are the key details about the study, such as its purpose, duration, required procedures, key contacts as well as risks and potential benefits associated with it. The participant then decides whether or not to sign the consent and participate in the study.
Informed consent is not a contract, and the participant may withdraw from the trial at any time.
Main components of an informed consent forms are:
 Information about the sponsor conducting the research.
 The main objective of the study.
 During the study how the research team will monitor the health and safety of the participants.
 As a participant the requirements for the follow-ups and the duration of the study.
 Possible benefits and risks associated.
 Other treatments those are available for the particular disease or condition.
 How the privacy of the medical records will be protected for the participating patients.
 Compensations if any for the participant’s time.
 The study staff also provides the participants a consent form, an agreement that he /she will sign if he /she decide to join the trial.

Mostly IRBs develop standard formats for informed consents as per FDA regulations and wherever changes are needed from the standard paragraphs or format; the investigators have to satisfy local IRB's concerns by explaining in the submission to the IRB why the changes are necessary.

To find out more about the regulations around Informed Consents follow the link:
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126431.htm

Building Related Illness (BRI)/ Sick Building Syndrome (SBS)

2009-12-22T11:29:00.000-08:00

BayBiotech.NET
Built environments both residential and non residential are subject to number of indoor air quality (IAQ) and Indoor environment (IE) problems that may cause acute symptoms, health risks or discomfort.
A frequent IAQ and IE investigations can determine the occurrence of BRI and provide with healthier work environment. This is of utmost importance for Pharmaceutical/ Life Sciences industry where the product is directly subject to the human usage.
Non residential buildings are more prone to BRI as there is a high volume of occupants coming from diverse geographical areas interact in an environment where the ventilation of the building is not directly under the occupants control.
Health hazard evaluation teams from the National Institute of Occupational Safety and Health (NIOSH) conducts the investigation upon request and provides with strategies to avoid the recurrence of the problem. Some of the risk factors that may be used to evaluate biological contaminants as potential causes of allergy/asthma/sinusitis are as follows:
1. Mold: active mold infestation on building material, building history of water damage, wet building site, musty odors, viable mold test results of >1000 CFU/m3 and total mold counts >10,000 S/m3.
2. Dust mites: damp interiors, > 2 ug/g mite allergen levels in floor dust samples.
3. Apart from dust mites and mold, bacterias are major contributors to indoor health hazards and some of the diseases caused due to them are Tuberculosis, Pneumonia, Diphtheria, Anthrax, Meningitis, Respiratory infections and wound infections.

Poor IAQ contributed by various identifiable factors may cause decreased work performance and may impose significant economic costs on employers. Thus, it is important to have a regular investigations planned to test the health of the buildings used for performing the work.

In the US, NIOSH has developed a protocol to serve the needs of its health hazard evaluation teams. Such a team consists of an industrial hygienist, an epidemiologist, and a technical person familiar with the operation and maintenance of building mechanical systems.

To find out more on the topic, you may want to follow the readings as under:

1. www.epa.gov
2. USEPA/ NIOSH, EPA/400/1-91/003, DHHS Publication No. 91-1141-1991.
3. Thad Godish, Indoor Environmental Quality, CRC Press LLC, 2001.

Protection of Human Subjects & Constitution of IRB

2009-12-18T10:57:00.000-08:00

BayBiotech.NET
Scope: the policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency which takes appropriate administrative action to make the policy applicable to such research.
This policy does not affect any state, local or foreign laws or regulations which may otherwise be applicable and which provide additional protections for human subjects.
Exclusions:
 Research conducted in educational settings, examples: research on education instructional strategies, on comparison among instructional techniques, curricula, or classroom management methods.
 Research involving survey procedures, interview procedures or observation of public behavior, unless information is recorded in such a manner that human subjects can be identified.
 Research involving the collection of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers.
 Research and demonstration projects which are conducted for the approval of department or agency heads, and are designed to study, evaluate, or examine:
Public benefits, procedures for obtaining benefits or services under those programs;
 Taste and food quality evaluation and consumer acceptance studies,
Institutional Review Board: Each and every institution engaged in research on human subjects has a review board to determine the compliance of submitted research proposal with local, state and federal regulations with main focus to protect violations of human subjects in terms of privacy and confidentiality of information. Such review boards are called IRB (Institutional Review Board) and as per NCI’s definition, “IRB is a group of scientists, doctors, clergy, and consumers that reviews and approves the action plan for every clinical trial. There is an IRB at every health care facility that does clinical research. IRBs are designed to protect the people who take part in a clinical trial. IRBs check to see that the trial is well designed, legal, and ethical, does not involve unnecessary risks, and includes safeguards for patients”.
According to Title 45, part 46 an IRB must constitute of the following:

(1) Each IRB shall have at least five members, with varying backgrounds of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice in safeguarding the rights and welfare of human subjects.

(2) In order to determine the acceptability of proposed research in terms of institutional commitments and regulations, applicable local, state and federal law, and standards of professional conduct and practice, IRB shall include persons knowledgeable in these areas.

(3) If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(4) Every effort must be made to ensure that no IRB consists entirely of men or entirely of women.

(5) An IRB must not consist of entirely members from one profession.

(6) Each IRB shall include at least one member from scientific area and at least one member from nonscientific areas.

(7) IRB shall include at least one member who is not affiliated with the institution and is not part of the immediate family of a person affiliated with the institution.

(8) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest.

(9) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise.
For further readings, follow the link: http://www.hhs.gov/ohrp/documents/OHRPRegulations.pdf

Good Pharmacovigilance Practices (GPPs)

2009-12-15T11:22:00.000-08:00

BayBiotech.NET
Pharmacovigilance is a branch that involves the identification and evaluation of safety signals generated by the usage of a medical product.

Safety Signal: is a concern raised when excess of adverse events are observed compared
to what would be expected with a product's use. Signals can arise from collection of post marketing data, preclinical data and events associated with other products in the same pharmacologic class.

Even a single well-documented case report can be viewed as a signal, particularly if the report describes an event that is extremely rare in the absence of drug use.

Signals indicate the need for further investigation, which may or may not lead to the conclusion that the product caused the event.

After a signal is identified, it should be further assessed to determine whether it represents
a potential safety risk and whether other action should be taken.

Good Pharmacovigilance Practice is based on acquiring complete data from
spontaneous adverse event reports, also known as case reports.

In order to understand and interpret the adverse events, good and well documented reports are emphasized following Good Reporting Practice guidelines:

Good Reporting Practices

A good and well documented Case reports of adverse events submitted to the sponsor and FDA, as well as reports from the medical literature or clinical studies, may generate signals of adverse effects of drugs.

A good quality report is critical for appropriate evaluation of the adverse events caused by the usage of the product.

FDA recommends that reasonable attempts be made to obtain complete information for case assessment during initial contacts and subsequent follow-up, especially for serious events.

Sponsors may use trained and well informed health care practitioners to query reporters.

Computer-assisted interview technology, targeted questionnaires, or other methods developed to target specific events can help focus the line of questioning.

When the report is from a consumer, it is often important to obtain permission to
contact the health care practitioner familiar with the patient’s adverse event to obtain further
medical information and to retrieve relevant medical records, as needed.

It is further recommended that the most aggressive follow-up efforts be directed towards serious
adverse event reports, especially of adverse events not known to occur with the drug.

To find out more about FDA’s guidelines on Good Pharmacovigilance Practices follow the link as under:
http://www.fda.gov/cder/guidance/6359OCC.htm

Pharmacokinetics, Pharmacodynamics and much more.....

2009-12-11T16:33:00.000-08:00

BayBiotech.NET
This blog is focused on discussing some of the terminology you may come across while dealing with Quality Control/Assurance or regulatory compliance in a Pharmaceutical/ Life sciences Industry environment.
We may not dedicate many blogs on this, but briefly going over them, will provide us the acquaintance with theses terms and may help understand them better whenever they are referenced in other documents/ blogs. These are as follows:

Pharmaceutics: discipline of pharmacology that involves evaluation, design and preparation of suitable dosage forms of chemical entities and delivery systems. This discipline is targeted towards optimizing drug action as well as minimizing adverse effects. Pharmaceutics involves studies from interdependent areas such as physical chemistry, biochemistry, analytical chemistry, mathematics, chemical engineering, molecular and cellular biology, pharmacology, anatomy and physiology.

Pharmacokinetics: is the study of the time course of drug in different fluids, tissues, and excreta of the body (effect of body on the drug).

ADME (T): is a term used for absorption, distribution, metabolism, excretion and toxicology studies.

Pharmacodynamics: study of the physiological effects of ingested drugs within or on the body. (effect of drug on the body).

Pharmacogenomics: study of how an individual's genetic constitution affects body's response to drugs.

Pharmaceutical Formulation: process in which different substances, including the active drug, are combined to produce a final medicinal product.

Biologics: studying a wide range of medicinal products of biological origin. Examples are vaccines, blood and blood components, allergenic, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. In most of the jurisdictions worldwide, biologics are regulated in a different manner than are drugs and medical devices.

Bioequivalence: United States Food and Drug Administration (FDA) has defined bioequivalence as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study. These studies are mainly conducted to compare two products such as a commercially-available Brand product and a potential to-be-marketed Generic product.

Bioavailability: is the fraction of the administered dose that reaches the systemic circulation.

Potency and Efficacy: Potency refers to the amount of drug (usually expressed in milligrams) needed to produce an effect. Efficacy refers to the potential maximum therapeutic response that a drug can produce.

Dose Response: measured as LD50 or statistically-derived dose that is lethal to 50% of a modeled population.

Pharmacovigilance: is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications.

References:

1. Gibaldi, M. and Perrier, D. 1975 Pharmacokinetics, Marcel Dekker, page v.
2. J. Lazarou, B. H. Pomeranz, and P. N. Corey. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA. Apr 15, 1998. 279(15):1200-5.
3. J. Hodgson, and A. Marshall. Pharmacogenomics: will the regulators approve? Nature Biotechnolgy. 16: 243-246. 1998.
4. S. Pistoi. Facing your genetic destiny, part II. Scientific American. February 25, 2002.
5. Genomics.energy.gov
6. Wikipedia (en.wikipedia.org)
7. accelrys.com
8. http://www.fas.org/ota/reports/7401.pdf
9. http://aquaticpath.umd.edu/appliedtox/dose-response.pdf
10. www.fda.gov

Different Types of Clinical Trials

2009-12-08T10:41:00.000-08:00

BayBiotech.NET
We often think of clinical trials as a principle method of studying new drugs, but there are many different types of trials that are designed to answer different questions related to health care and well beings of the human subject. Understanding the objective of your clinical trial and the entire process is the first step taken towards determining the regulatory pathways that will apply to a particular study. Depending on the end-goal different types of clinical trials are as under:
• Prevention trials – Prevention trials look at substances and lifestyle factors that may raise or lower the risk of developing a clinical condition. e.g. effect of a particular type of food or exercise on preventing Diabetes.
• Screening trials – Screening trials are designed to diagnose a condition in its early stages when it is often more curable. e.g. a newly developed imaging technique if used to screen breast cancer occurrence.
• Diagnostic trials – Diagnostic trials are aimed to evaluate the methods to detect a clinical condition or to accurately measure the levels of a biomarker associated with the condition. E.g. various trials to test a newly developed kit for HIV.
• Treatment trials – Treatment trials evaluate the ability of drugs, radiation, surgery, or other measures to treat a medical condition. These are the most conventional type of clinical trials and most tedious ones in terms of usage of times as well as resources.
• Supportive care trials – Supportive care trials are also called quality-of-life trials. They study the ability of a drug or procedure to lessen the symptoms related to a condition. These trials are mainly designed around device developments.
Out of all the abovementioned trials, Treatment Trials are the most conventional types and referred while mentioning the clinical trials.
References: ClinicalTrials.gov & Medpedia.com

Quality Assurance and Compliance: Industrial Environmental Management Systems

2009-12-04T11:42:00.000-08:00

Quality Assurance and Compliance: Industrial Environmental Management Systems

BayBiotech.NET

FDA’s Adverse Event Reporting System (AERS) Database

2009-12-04T11:35:00.000-08:00

BayBiotech.NET
AERS is a computerized information database designed to support FDA’s post marketing safety surveillance program for drug and biological products.
The AERS database is used to store and analyze data received in post marketing safety reports submitted in form of reports by companies. FDA recently proposed to submit the reports in electronic format in order to achieve the following objectives:
1. Eliminate the time and costs associated with submitting paper reports.
2. Expedite the agency’s access to safety information
3. Enhance agency’s ability to rapidly communicate information about suspected problems to health care providers, consumers, applicants, and sponsors within the United States and internationally.

The proposal is developed considering international standards guidelines (ICH) and was open for public comment between August- November, 2009. To read more about the proposed rules follow the link: http://edocket.access.gpo.gov/2009/pdf/E9-19682.pdf

Industrial Environmental Management Systems

2009-12-01T11:44:00.001-08:00

BayBiotech.NET
Environmental Management Systems (EMS) can be considered as a tool to manage the environmental quality policies and procedures as per Industry standards and regulatory guidelines. EMS provides a framework to efficiently operate organizational responsibilities and activities in most efficient ways keeping the risk to the environment at its minimum. EMS also provides scope to the organization to implement corrective and preventive plan in order to continuously improve the environmental performance. An effective management system ensures that adequate efforts are properly deployed in regard to training, monitoring and reporting.

Three main environmental guidelines that fall within the scope of Biotech/ Life Sciences Industry and will need integration with EMS are:

RC14001: Responsible Care® (RC) is a voluntary initiative of the worldwide chemical industry with a focus on an on-going efforts to improve the safety and the protection of health and the environment, applicable not only to the organization but to the entire supply chain. The program was first introduced in 1988 by the American Chemistry Council (ACC) to address public concerns about the manufacture and use of chemicals and so far has been adopted in over 45 countries. To further strengthen the program,
ACC integrated the Responsible Care® requirements into the globally accepted Environmental Management Standard, ISO 14001.Responsible Care® principles in some form or other have been long adopted by leading organizations in the chemical industry. (http://www.techstreet.com/)
OHSAS18001: OHSAS 18001 standards were created by concerted efforts of the world’s leading national standards bodies, certification bodies, and specialists for occupational health and safety standards. The OHSAS specification is applicable to any organization that wishes to establish an OH&S management system to eliminate or minimize risk to employees and other interested parties who may be exposed to OH&S risks associated with its activities and provides guidelines to implement maintain and improve an OH&S management system.( http://www.osha-bs8800-ohsas-18001-health-and-safety.com/ohsas-18001.htm)
ISO14001: The ISO 14000 family addresses various aspects of environmental management. The very first two standards, ISO 14001:2004 and ISO 14004:2004 deal with environmental management systems (EMS). ISO 14001:2004 provides the requirements for an EMS and ISO 14004:2004 gives general EMS guidelines.
 ISO 14001:2004 provides a generic requirement for an environmental management system. The underlying philosophy is that whatever the organization's activity, the requirements of an effective EMS are the same, whereas:
 ISO 14004:2004 provides guidelines on the elements of an environmental management system and its implementation, and discusses principal issues involved. (http://www.iso.org/)

Tougher HIPAA Rules around HITECH

2009-11-23T22:15:00.000-08:00

BayBiotech.NET
The Health Information Technology for Economic and Clinical Health Act ( HITECH), intended to promote adoption of information technology for maintenance of electronic health records and incorporated into the American Recovery and Reinvestment Act of 2009, was signed into law on Feb. 17, 2009. The key points of the provisions are:
1. Tracking the medical information disclosure: According to the new legislation, physicians will be required to track any disclosure of a patient's medical information. Previously regulations allowed physicians to disclose patient information for the purpose of treatment, billing or health care, but they were not required to track when that information was disclosed. This provision kicks in for current users on Jan. 1, 2014, and then patients will be able to request an accounting of disclosures of their electronic personal health information three years from the date of the request, potentially dating back to 2011.

2. Rules regarding security breaches new legislation require practices to post information about security breaches if a breach affects 10 or more patients. If a security breach affects 500 or more patients, practices must notify all of their patients, a local media outlet, and the HHS secretary. New enforcement also escalates the fines for the security breaches ranging anywhere between $100- $1.5 million.
Thus the new legislation provides more control to the patients over the handling of their health care records, but increases the costs and risks for a health care facility for protecting the health information. This will also mean that health care facilities will have to spend more resources and develop infrastructure to keep the electronic health care records secure. This regulation also opens avenues for the emergence of contract health care management facilities that can be used to outsource handling of the patient’s health care information and thus will help save resources and will keep the costs manageable for the health care facilities.
(Ref: www.hhs.gov/ocr/hipaa/)

Globalization of Clinical Trials

2009-11-20T09:16:00.000-08:00

BayBiotech.NET
When ICH was conceived in 1999, it was for a good cause understanding that it will have harmonization on guidelines for conduct of a clinical trial worldwide as it brought together European Union, United States and Japanese experts together to draw a set of standards that would streamline the clinical research globally. Out of thirty-eight topics (Guidelines) originally identified, only the ICH E6 document relates to the standards of Good Clinical Practice. Since, the EU Directive were set in place for conducting a clinical trial in UK and European member states it is not only ICH E6 but also EU GCP Directive 2001/20 and 2005/28 that is required to be followed which gives a higher standard than ICH E6 alone. Apart from these directives, member states of the European States have their local laws that are also incorporated into the GCP conducts.
This further complicates the conduct of clinical trials and acceptance of global data because if a member state selects a site outside EU members, whether it is in Japan, Australia, Canada or United States will have to follow all the above mentioned directives to be in compliance. Similarly, if a drug is developed and clinical trials are conducted in United States or any other country following FDA GCP guidelines will have problems getting marketing clearance within EU member states as the trial may have only followed FDA GCP but not EU directives.
Seems with globalization of the clinical trials and drug discovery efforts, a revision of harmonization is due and till then a clear expert understanding of local regulations of the countries where trial sites are selected will be helpful. Note that the country of choice for clinical trials must be followed closely for their local regulations as amendments are incorporated all the times and in order to get a higher success rate with the trial data acceptance a close follow-up on local GCP regulations will be helpful.

Conducting Audits for Contract Research Organizations (CROs)

2009-11-18T11:21:00.000-08:00

BayBiotech.NET
Performing site visits to your CROs for compliance audits at certain time intervals ensures the integrity and quality of data you are receiving for the clinical research. Sponsor audits also set stage for engaged CROs to prepare for direct FDA audits and leads to increased chances of success.
Audits may be either routine audits to check the facilities for compliance or may be based on the performance or any non-compliance issue that may have come in the highlight during the course of the study. In either case an audit provides CROs with timely opportunity to take corrective and preventive action measures and makes the CRO facility aware of sponsor’s vigilance leading to compliance on their part as well as best outcomes of financial investment for the sponsor.
Before performing an audit, an audit plan must be drafted by the auditor specifically preparing a check list of the items or issues that are recognized as critical steps of the procedures performed at CRO sites. This information might be gathered from the team members at sponsor’s organization who have been involved in developing the SOPs (Standard Operating Procedures) and standards for the studies conducted at the CRO site. It is the job of the auditor to ensure that the audit plan and the accompanying checklist have all the critical components included relevant to the quality performance.
After finalizing the plan and a checklist, auditor must have the higher management’s approval for the same before visiting the CRO site. Some of the important components to include in auditor’s checklist for a CRO visit are: checking for completeness of training records of the employees, making sure the current version of SOPs are in use, facility is 21CFR Part 11 compliant, ensuring that critical steps of the procedures are performed according to the protocol as well as the general health of the facility appears to be of standard quality as well as in accordance with different federal and state compliances. A successful auditor must also be able to understand the complete reporting structure and roles and responsibilities of the employees at the CRO site.
Once the audit is completed, auditor must present a report with important findings highlighting the non-compliance issues within a month’s time frame and communicate the findings to the higher management and consecutively to the CRO for corrective and preventive actions.

Implementing Quality Management Systems for FDA Environment

2009-11-13T11:00:00.001-08:00

BayBiotech.NET
A quality management system (QMS) is a collective term for a management framework comprising of policies, plans, practices, and the supporting infrastructure by which an organization aims to reduce, eliminate and maintain non-conformance to specifications, standards, and customer expectations in the most cost effective and efficient manner.
Quality management systems are relevant especially for healthcare/ Biotech/Pharmaceutical industry that are regulated by FDA. All organizations whether large or small, public or private, manufacturing or service oriented are benefited by implementing a quality management system. Although a small company may have an in-house developed QMS system to manage the compliance and meet the production specifications for internal as well as external regulatory requirements, eventually it becomes difficult to manage the same in larger companies or multinationals. As it is obvious that for best results QMS must be implemented globally in an organization rather than specifically working with few departments.
Many companies have developed industry specific Quality Management System softwares and few are listed here:
IBS: http://www.ibs-us.com/
CEBOS: http://www.cebos.com/
ETQ: http://www.etq.com/
BSi: http://www.bsigroup.com
Master Control: http://www.mastercontrol.com/
In order to get the best benefits out of QMS software, while evaluating, ensure that it is customizable, scalable as well as meets the most critical cirterias of your business. Best approach would be to gather the quality needs of all the departments to ensure that the software can be customized to meet and keep the quality criterias of the organization.

What to include in Traditional 510(k) Filing for Medical Devices

2009-11-10T10:50:00.000-08:00

BayBiotech.NET
A 510k is a premarket submission made to FDA to demonstrate that a medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device.
A Traditional 510(k) submission must include the required elements as per 21 CFR 807.87 (Information required in a premarket notification submission):
 the name of device, (the trade or proprietary name), if any, and the common or usual name or classification name of the device.
 description of the device, include device specifications and reference applicable guidance documents, special controls, or standards; photographs or engineering drawings should be supplied, if applicable.
 comparison with a predicate device(s), indicating similarities and/or differences accompanied by data, as appropriate; this information may include an identification of materials, design considerations, energy expected to be used or delivered by the device, and a description of the operational principles of the device.
 intended use of the device,
 proposed label, labeling, and advertisements for the device and directions for use.
 Information on sterilization, biocompatibility, expiration date, etc., if applicable.
Important elements of a Traditional 510(k) filing include:
• Medical Device User Fee Cover Sheet (Form FDA 3601).
• CDRH Premarket Review Submission Cover Sheet
• Certification of Compliance with ClinicalTrials.gov Data Bank, FDA-3674
• Cover letter
• Table of Contents (recommended)
• Indications for Use
• 510(k) Summary (21 CFR 807.92) or 510(k) Statement (21 CFR 807.93)
• Standards Data Report for 510(K) s - FDA 3654. Submit this form if your 510(k) references a national or international standard.
• Truthful and Accuracy Statement (21 CFR 807.87(k))
• Class III Certification and Summary for Class III devices (21 CFR 807.94)
For more details on the procedure and forms visit official FDA website at:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070202.htm

Nanotechnology Interest Group

2009-11-06T09:30:00.000-08:00

BayBiotech.NET
As per definition of National Technology Initiative, nanotechnology is the understanding and control of matter at dimensions between approximately 1 and 100 nanometers. Encompassing nanoscale science, engineering, and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale. According to NTIG at this scale unusual physical, chemical, and biological properties can emerge in materials and the properties may differ in important ways from the properties of bulk materials and single atoms or molecules.
Recognizing a great potential for this technology for drug delivery/ device in medicine, in July 2007 FDA issued a press release outlining the regulatory challenges that the implementation of the technology will have for the agency and geared up towards developing guidance as well as regulations to address the benefits and risks of drugs and devices using nanotechnology. As it is obvious, development and Implementation of nanotechnology in medical field will require multiple expertise (device, drug, engineering and more) agency has formed a nanotechnology interest group (NTIG) to facilitate the regulation of nanotechnology products. NTIG is made up of representatives from multiple centers (so far FDA and 22 other federal agencies are members) and meets quarterly to ensure there is effective communication between the Centers. Most of the Centers also have working groups that establish the network between their different components. To find out more about the national Nanotechnology Initiative visit http://www.nano.gov/.
For more information on the agencies outlook on Nanotechnology products if you have an interest in developing a drug or device at nanoscale visit the link: http://www.fda.gov/ScienceResearch/SpecialTopics/Nanotechnology/default.htm

International Compilation of Human Research Protections 2009 Edition

2009-11-03T10:55:00.000-08:00

BayBiotech.NET
Office for Human Research Protections (U.S. Department of Health and Human Services) has compiled a list of 1,100 laws, regulations, and guidelines governing human subject’s research in 92 countries, as well as standards from a number of international and regional organizations.

This 85 pages list has been developed for IRBs/Ethics Committees, researchers, sponsors, and others who are involved in international research with a purpose to help these groups familiarize themselves with the laws, regulations, and guidelines where the research will be conducted, to assure those standards are followed appropriately.

The 2009 Edition is the latest updated version that includes numerous additions and updates to the 2008 Edition, and further includes the laws, regulations, and/or guidelines for 7 new countries: Burma (also known as Myanmar), Egypt, the Gambia, San Marino, South Korea, the Sudan, and Vietnam.

If you are clinical research personnel and would like to get the latest understanding of guidelines and regulations governing clinical research in different countries, check out this link to update yourself:
http://www.hhs.gov/ohrp/international/HSPCompilation.pdf

Post FDA Amendments Act of 2007: New Definition of Pharmacovigilance

2009-10-29T15:33:00.000-07:00

BayBiotech.NET
Recent FDA Amendments Act of 2007 has emphasized needs of active adverse event surveillance methods linking multiple sources of clinical data for analysis and further mandates creation of effective tools for post market risk identification, assessment and management of adverse events.
Legislation recognizes the limitations of traditional mainstream drug safety practices in the pharmaceutical industry that depends on the collection and analysis of safety data from clinical trials and therefore emphasizes the need of data mining from multiple sources.
In past few years, emerging need of data mining has generated lot of interest among various competitors to develop tools within the limits of privacy and confidentiality limits to meet the drug safety needs.
FDA is in the process of currently exploring, testing, and developing new methods of signal detection, data mining, and analysis of patient-level electronic healthcare data hoping that these new developed methods will complement the existing passive post market surveillance system.

To find out more about FDA’s E2E Pharmacovigilance Planning visit the link: http://www.fda.gov/RegulatoryInformation/Guidances/ucm129411.htm#f1

European Union’s Clinical Trials Directive

2009-10-26T15:32:00.000-07:00

BayBiotech.NET
Following is a summary of the key points on the laws, regulations and Good Clinical Practices of the Member States as per European Union’s Directive for conduct of Clinical Trials on human subjects:

1. Directive requires that applications for authorization to place a medicinal product on the market should be accompanied by a dossier containing particulars and documents relating to the results of tests and clinical trials carried out on the product. A dossier must be prepared in compliance with uniform rules laid down by the Member States.

2. A detailed risk assessment and management strategy must be in place based on the toxicological data derived at Pre-clinical research stage.

3. Persons who are incapable of giving legal consent such as dementia, psychiatric patients etc. to clinical trials should be given special protection. Such persons may not be included in clinical trials if the same results can be obtained using persons capable of giving consent. These persons should be included in clinical trials only when there are grounds for expecting that the administering of the medicinal product would be of direct benefit to the patient. However, if possible clinical trials must involve children in order to evolve better treatments for them.

4. In order to achieve optimum protection of health, obsolete or repetitive tests will not be carried out, whether within the Community or in third countries. Such initiatives must be conducted through the International Conference on Harmonization.

5. For Medicinal Products intended for gene therapy or cell therapy, prior scientific evaluation by the European Agency for the Evaluation of Medicinal Products assisted by the Committee for Proprietary Medicinal Products, is mandatory before the Commission grants marketing authorization.

6. Information on the content, commencement and termination of a clinical trial should be available to the Member State where the trial takes place and all the other Member States should have access to the same information.

7. As a rule, if there has been a vote in favor by the Ethics Committee and the competent authority has not objected within a given period, it should be possible to begin the clinical trials. In exceptional cases especially for complex problems/ treatments, explicit written authorization should be obtained.

8. The principles of good manufacturing practice should be applied to investigational medicinal products and for the labeling of these products.

9. The person participating in a trial must consent to the scrutiny of personal information during inspection by competent authorities and properly authorized persons, provided that such personal information is treated as strictly confidential and is not made publicly available.

10. It is also necessary to make provision for the monitoring of adverse reactions occurring in clinical trials using Community surveillance (pharmacovigilance) procedures.

Thus, this provides a snapshot of the key elements of EU’s Clinical Trials Directive. The information provided here is extracted from Official Journal of the European Communities (1.5.2001): L 121/34- 44.

Risk Assesment and Management of Electronic Health Information

2009-10-21T09:08:00.002-07:00

BayBiotech.NET
Health Insurance Portability and Accountability Act of 1996 (HIPAA, Title II) required the Department of Health and Human Services (HHS) to establish national standards for the security of electronic health care information.
Department of Health and Human Services prepared certain guidelines that specify a series of administrative, technical, and physical security procedures for covered entities to use to assure the confidentiality of electronic protected health information (EPHI). This is particularly relevant for organizations that allow remote access to EPHI through portable devices or on external systems or hardware not owned or managed by the covered entity. Guidelines address mainly the privacy of health information issues that may arise by using laptops; home-based personal computers; PDAs and Smart Phones; hotel, library or other public workstations and Wireless Access Points (WAPs); USB Flash Drives and Memory Cards; floppy disks; CDs; DVDs; backup media; Email; Smart cards; and Remote Access Devices (including security hardware).
A significant emphasis and attention is paid on organization’s Risk analysis and risk management strategies; setting up Policies and procedures for safeguarding electronic data as well as Security awareness and training on the policies & procedures for safeguarding the health information if used electronically via remote access.
Main focus has been placed on the risks associated with remote access and offsite use of the EPHI into three areas: access, storage and transmission.

A good risk management planning takes all three areas into account and may vary from one organization to the other depending on the size, usage and infrastructure of the organization.

To read more about the risks assessment and management strategies suggested by HHS, follow the link: http://www.cms.hhs.gov/SecurityStandard/

European Union Safe Harbor Policy

2009-10-19T09:56:00.000-07:00

BayBiotech.NET

The European Commission’s Directive on Data Protection w.e.f.October of 1998 prohibits the transfer of personal data to non-European Union nations that do not meet the European “adequacy” standard for privacy protection of the personal data. For purposes of the policy, "personal information" means information that:

 is transferred from the European Union to the United States;
 is recorded in any form;
 is about, or pertains to, a specific individual or can be linked to that individual.
While both the United States and the European Union share the goal of enhancing privacy protection for their citizens, the United States takes a different approach to privacy from that taken by the European Union.
With a goal to bridge the different privacy approaches between the United States and European Union and provide a streamlined means for U.S. organizations to comply with the Directive, the U.S. Department of Commerce in consultation with the European Commission developed a "Safe Harbor" framework to provide the information an organization should need to evaluate – and then join – the Safe Harbor.
Safe Harbor Directive applies to all personal information that is handled by an organization, including on-line, off-line, and manually processed data.

Where the company receives personal information from its subsidiaries, affiliates, or other entities in the EU, the company will use and disclose such information in accordance with the purposes for which it was originally collected, or in accordance with the notices provided by such entities.
The company will provide notice and provide individuals with an opportunity to "opt out" if such personal information is to be disclosed to a third party or used for a purpose incompatible with the purpose for which it was originally collected.
For sensitive information, affirmative or explicit, the company will provide notice and individual choice will be given to "opt-in" if such sensitive information is to be disclosed to a third party or used for a purpose other than the purpose for which it was originally collected. In order to disclose such information, one must have individual’s permission to make the disclosure required by law or professional standards providing adequate level of privacy protection and is reasonably related to the sale or other disposition of the business.

For data security purposes, the organization must employ various physical, electronic, and managerial measures, designed to provide personal information with reasonable protection from accidental loss or destruction, improper use, alteration, or disclosure.

The EU’s Data Protection Directive, implemented in 1998, provides member states with the authority to block such transfers to countries whose privacy enforcement regime does not meet the directive’s requirements. Under the US-EU Safe Harbor Framework, the United States received an “adequacy” determination from the European Commission limited to those U.S. organizations that self-certified to Safe Harbor which allows data transfers to take place without prior approval.
To find out more about the Safe Harbor Framework and the qualification Checklist follow the link:
http://www.export.gov/safeharbor/

FDA's Critical Path Initiative

2009-10-14T09:46:00.001-07:00

BayBiotech.NET

FDA launched its Critical Path Initiative (CPI) in March 2004, with the release of a report “Innovation/Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products”. This report highlights the reasons for the widening gap between modern scientific discoveries with a potential to prevent and cure some of today's biggest medical challenges, and their translation into innovative medical treatments. The main reason identified was being Industry’s apprehension to adapt and train to new technologies that might delay launch of the product into the consumer market.
In order to ease out the apprehension, FDA recognized the need for a collective action to modernize the scientific and technical tools and introduced CPI and calls for incorporating specific activities into the medical development path that would help modernize the critical path sciences. CPI has seen the number of its projects grow from 40 in 2006 to 95 in 2009.
FDA is collaborating with other federal agencies, patient groups, academic researchers, industry, and other stakeholders to identify areas with a potential for improvement and to coordinate and develop solutions to overcome scientific hurdles that are impairing the efficiency of developing and evaluating FDA regulated products.
To explore more to find out about FDA’s CPI Opportunity lists, visit the link:
http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/ucm076689.htm

Clinical Trial Risk Assessment & Management Plan

2009-10-13T09:40:00.000-07:00

BayBiotech.NET

Before the onset of a trial the study director/sponsor must have a risk assessment and risk management plan to accompany the filing to IRB or FDA for IND or PMA applications.

Hazard is defined as anything that could cause harm and risk is the probability of that harm caused by the hazard.

Risk Assessment Plan for each potential hazard includes mapping and analysis of associated risks, its potential consequences and reasonable steps to reduce the risks.

In a clinical trial hazards are categorized into main four groups:

1. Hazards for the participants that encompasses protecting participant’s rights.

2. Hazards for the participant’s safety by assessing the likely risk/ benefit ratio in the study population.

3. Hazards of the trial with risk associated for recruitment and follow-up.

4. Hazard to the reliability of the results mainly in terms of study power and adherence to the protocol.

Risk Management Plan includes detailed strategies and considerations to reduce/ minimize the above mentioned hazards customized for a particular study.

It will be Study Director/ Sponsor’s responsibility to educate all the professionals involved in the trial to be aware of the Risk Assessment and Management Plan for a successful trial completion.

Quality that Matters for Life Sciences Venture: Risk Evaluation and Mitigation Strategies Guidance for Pharmaceutics and Biologics

2009-10-12T10:07:00.000-07:00

Quality that Matters for Life Sciences Venture: Risk Evaluation and Mitigation Strategies Guidance for Pharmaceutics and Biologics

BayBiotech.NET

Risk Evaluation and Mitigation Strategies Guidance for Pharmaceutics and Biologics

2009-10-12T10:06:00.000-07:00

BayBiotech.NET

FDA has posted draft guidance for Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications on its website. The draft guidance has been posted in September 2009 and is open for comments and feedbacks from all that may have an interest
in the subject.

In a nutshell, the guidance authorizes FDA to require the applicants of NDA (new drug applications), ANDAs (abbreviated new drug applications), and biologics license applications (BLAs) to submit a proposed
Risk Evaluation and Mitigation Strategies (REMS) within 180 days once notified by FDA and may come to the applicant, if FDA becomes aware that such a strategy might be necessary to ensure that the benefits of the drug outweigh the risks of the drug in question.

Before September 2007, when the Food and Drug Administration Amendments Act of 2007 (FDAAA) was signed, FDA used to approve a small number of drug and biological products with risk minimization action plans (RiskMAPs) that was considered to be a strategic safety program designed to meet specific goals and objectives in minimizing known risks of a product while preserving its benefits.

RiskMAPs were developed for products that had risks that required additional risk management strategies beyond describing the risks and benefits of the product in labeling and performing required safety reporting.

Since now FDAAA has given FDA the authority to require REMS when necessary to ensure that the benefits of a drug outweigh the risks, if FDA determines even after approval of the product, that a REMS is necessary even if the drug had satisfied the RiskMAP requirements, the involved party may have to submit REMS plans if notified by the agency.

Although, there are number of overlaps that eventually will be carried over from RiskMAPs to REMS,
to further understand the details of the expected content of REMS submission, follow the link provided here:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf

QA & Regulatory Compliances etc.: ISO Management Standards for Medical Devices

2009-10-06T14:44:00.000-07:00

QA & Regulatory Compliances etc.: ISO Management Standards for Medical Devices

BayBiotech.NET
www.baybiotech.net

ISO Management Standards for Medical Devices

2009-10-06T11:32:00.000-07:00

Two main ISO standards that have a direct application to Medical Device Industry are ISO 9001 and ISO 13485.

While ISO 9001 is for evolving a Quality Management System for an organization, ISO 13485 has a direct application to Medical Device Industry.

Although, ISO standards for a company are not a legal requirement, but provide a validation and ease of global marketing of the product.