Application of BCS (Biopharmaceutics Classification System) in New and Generic Drug Reviews

The US Food and Drug Administration (FDA) issued its final guidance on this topic in August 2000 and, since then, scientific principles and criteria outlined in this guidance have been successfully utilized to obtain a waiver of BE studies by both the innovator and generic industries. Dr. Mehul Mehta has been involved with the development of this agency guidance from the start and currently co-chairs the committee overseeing the implementation of the guidance in the review divisions. This webcast will provide a brief overview of the guidance, a detailed discussion of the Center for Drug Evaluation and Research’s (CDER) BCS Committee’s role, functioning and a summary of all the products reviewed to date, a few examples and possible future updates.