PDUFA Reauthorization Process Begins

Reauthorization of the Prescription Drug User Fee Act is officially underway with the FDA’s announcement of a July 15 public meeting to assess the current PDUFA V.

In particular, the FDA wants to know how PDUFA might be tweaked to improve the efficiency and effectiveness of the drug review process. Stakeholder presentations should focus on process enhancements and funding issues, rather than policy issues, a Federal Register notice says.

PDUFA V is set to expire in September 2017, and the sixth iteration will set user fees and review goals for fiscal years 2018 to 2022.

The meeting will be held at the FDA’s White Oak Campus. To register, go to http://pdufapublicmeeting.eventbrite.com. The registration deadline is June 30.

Electronic comments may be submitted at www.regulations.gov through Aug. 15. Read the Federal Register notice at www.fdanews.com/05-13-15-PDUFA.pdf. — Kellen Owings