FDA Issues Final Rule and Draft Guidance on Safety Reporting Requirements for Investigational New Drugs and Biological Products

AGG Partner William H. Kitchens and Associates Jennifer S. Blakely and Lanchi Nguyen authored an AGG Client Alert that ran in full on BioSpace, an online community for the life sciences industry. The Food and Drug Administration (FDA) recently issued a final rule to clarify the requirements governing safety reporting requirements for human drug and biological products subject to an investigational new drug application and to impose bioavailability and bioequivalence studies to safety reporting requirements. The final rule, which becomes effective March 28, 2011, was concurrently published with draft guidance for industry and investigators. This article provides an overview of the more significant provisions of the final rule and the related FDA guidance document. Please click here to read the article.