Clinical Operations-Design to Execution

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...

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 .

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 ...

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 al...

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 you...

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 ri...