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