On September 17, 2014, the Food and Drug Administration (FDA) hosted the public hearing on Policy Development to solicit public comment on the five draft guidance documents that were issued to facilitate implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and on future policy priorities, including recommendations for additional guidance topics to facilitate GDUFA implementation. FDA also requested feedback on issues that may arise in consideration of 180-day exclusivity provided for by paragraph IV patent certifications (section 505(j)(5)(b)(iv) of the Federal Food, Drug, and Cosmetic Act or FD&C Act). Finally, FDA requested feedback on the specific criteria FDA that should apply to identify an abbreviated new drug application (ANDA) as a first generic eligible for expedited ANDA review. On May 2, 2015, the FDA posted a Federal Register notice reopening the public docket for an additional 30 days in response to requests that FDA provide an additional opportunity to submit comments on these topics.
Federal Register Notice Agenda for GDUFA Public Hearing on Policy Development(PDF - 68KB)
- Presentation by Priscilla Zawislak (IPEC Americas) (PDF - 113KB)
- Presentation by Steven Pressman (PureTek Corporation) (PDF - 57KB)
- Presentation by David Gaugh (GPhA) (PDF - 439KB)
- Presentation by Robert Vincent (Teva Pharmaceuticals USA) (PDF - 370KB)
- Presentation by Keith Webber (Perrigo plc) (PDF - 287KB)