Life is a Journey..how to make the best of it!

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