PDUFA Calendar by Month

About the PDUFA Calendar

PDUFA (Prescription Drug User Fee Act) dates are FDA's target dates for completing their review of new drug applications. These dates are critical for biotech investors as FDA decisions often lead to significant stock price movements.

Our monthly PDUFA calendar helps you track:

• PDUFA dates - FDA target action dates for drug approvals
• Clinical trial results - Phase 1, 2, and 3 trial readouts
• Advisory committee meetings - FDA panel reviews
• SEC filings - Important regulatory filings

Learn more about PDUFA dates and FDA approval process