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Publication|Articles|April 23, 2026
Pharmacy Practice in Focus: Oncology
- April 2026
- Volume 8
- Issue 3
Approval Pending: How to Plan for PDUFA Decisions
Author(s)Jordan Snyder, PharmD, BCOP
Fact checked by: Kirsty Mackay
Tracking PDUFA decisions and early planning can lead to safe, rapid access to new medications for patients.
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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.
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