FDA Wants Drugmaker Input on GDUFA
The FDA is seeking specific suggestions on potential changes to the Generic Drug User Fee Act performance goals and procedures, ahead of negotiations to reauthorize the law, which expires Sept. 30, 2017.
A public hearing will be held June 15 at the FDA’s White Oak Campus in Silver Spring, Md.
During a similar hearing in September, drugmakers listed a series of shortfalls in the generic drugs approval process, including the need for an overhaul of the inactive drug ingredients database to facilitate ANDA filing.
Electronic and written comments will be accepted until July 15. Persons interested in participating in the meeting should register by June 1. Read the Federal Register notice at www.fdanews.com/04-21-15-GDUFA.pdf. — John Bechtel