F.D.A. Says Millions Got Unapproved Drugs, Should the new bioequivalence and bioanalytical guidelines for 2010, be made more stringent

Plans by  FDA to Adopt stricter standards for Bioequivalence, Bioavailability for generic drugs could sound trouble for Indian Generic Manufactures. Already most of the smaller companies are finding it difficult to get FDA approval letters. QSR Draft Guidance An industry working group has urged the FDA to consider adopting its guidance to outline quality system requirements (QSR) for bioequivalence and bioavailability testing during drug clinical trials.

There was a recent report in NY times that mentioned about several thousand patients receiving nitroglycerin tablets that were not approved by FDA http://www.nytimes.com/2010/03/27/business/27nitro.html

FDA recently evaluated 2070 human studies conducted between 1996 and 2007. These studies compared the absorption of brand name and generic drugs into a person’s body. These studies were submitted to FDA to support approval of generics. The average difference in absorption into the body between the generic and the brand name was only 2.3%. Some generics were absorbed slightly more, some slightly less. This amount of difference would be expected and acceptable, whether for one batch of brand name drug tested against another batch of the same brand, or for a generic tested against a brand name. In fact, there have been studies in which branded drugs were compared with themselves, as well as with a generic. As a rule, the difference for the generic-to-brand comparison was about the same as the brandto- brand comparison” (www.fda.gov/ Drugs/ResourcesForYou/Consumers/ BuyingUsingMedicineSafely/Under standingGenericDrugs/ucm167991. htm)

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