Clinical Operations-Design to Execution

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) mon...

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…

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 Resea...

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 gu...

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 ...

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 procedure...

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 provi...