Drug safety comments
This article was originally published in The Tan Sheet
Executive Summary
FDA seeks comments on its draft drug safety five-year plan, according to a notice scheduled for publication in the May 5 Federal Register. The plan, released April 1, outlines how FDA will spend Prescription Drug User Fees, such as on hiring more safety inspectors for marketed medications and more staff to review mandatory post-approval studies, label changes and other risks (1"The Tan Sheet" April 14, 2008, p. 10). Comments are due in June...