FDA released its “goals letter” on performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) for 2018 – 2022. This is important news about the human drug review program — both for industry and patients. FDA is holding a public meeting on August 15; information can be found here, and you can register here.
Take a look at Zachary Brennan’s detailed summary in his article on RAPS. Brennan says the “goals letter” document tells how and where the FDA spends user fees from industry. It also communicates deadlines for upcoming guidance documents and new projects, and provides new review times for new drug applications (NDA) and biologics license applications (BLA) and more.