FDA and Industry Set Priorities Through Prescription Drug User Fee Act (PDUFA) Reauthorization

The FDA first began the Prescription Drug User Fee Act (PDUFA) reauthorization process in July. Now the agency has released the first set of meeting summaries of its ongoing negotiations with industry that will form the basis of its prescription drug review program from FY2023-2027.

The brief meeting summaries give a glimpse of what the FDA and industry hope to achieve through the multi-billion-dollar agreement. Both industry and the FDA agree that the rapidly advancing field of biologic therapies should be a top priority. Read more here.

(Source: Michael Mezher; Regulatory Focus; 10/29/20)