Approval Pending: How to Plan for PDUFA Decisions

Tracking PDUFA decisions and early planning can lead to safe, rapid access to new medications for patients.

Over the past 40 years, the FDA has approved an average of 31 new drugs annually. The number has continued to increase since the Prescription Drug User Fee Act (PDUFA) was approved.¹ As new drugs continue to proliferate, planning for FDA approval is an essential, multidisciplinary process.