Posted by Michael Wonder on 29 Jun 2017
FDA is reviewing generic applications faster, but what about those carryover fees?
28 June 2017 - Now that the FDA plans to fast-track generic drug applications in hopes of spurring competition and lowering medicines costs, a key question should be asked: can the agency follow through?
A new government report suggests that — yes, the FDA does have the wherewithal.
Thanks to a program in which industry pays fees so the FDA can more readily review drugs and inspect plants, the agency has already been reviewing generic drug applications at a faster clip. In fiscal year 2012, the agency spent 28 months on reviews, but that fell to 14 months by fiscal year 2015, according to a newly released report by the U.S. Government Accountability Office.
