PDUFA Calendar 2026 — FDA Drug Approval Dates

A PDUFA (Prescription Drug User Fee Act) date is the FDA's deadline to make a decision on a drug application. The FDA sets this date when it accepts a New Drug Application (NDA) or Biologics License Application (BLA) for review. It is typically 10 months after filing for a standard review, or 6 months for a priority review. PDUFA dates are among the most impactful binary events in biotech — stocks can move 50%+ in either direction.

The FDA almost never misses a PDUFA date outright. However, it can issue a Complete Response Letter (CRL) instead of an approval, requesting additional data, labeling changes, or manufacturing fixes. The FDA can also extend the review by 3 months via a Major Amendment if the company submits significant new information late in the review cycle.

A Complete Response Letter (CRL) is the FDA's formal notification that it cannot approve an application in its current form. CRLs typically cite clinical, manufacturing, or labeling deficiencies. Receiving a CRL often causes a 30-70% stock drop for biotech companies. The company can resubmit with additional data, which restarts a new PDUFA review cycle.

Standard review gives the FDA 10 months (12 months from filing date) to make a decision. Priority review shortens this to 6 months (8 months from filing date) and is granted when a drug offers a significant improvement over existing treatments for a serious condition. Priority review designation does not change the standard of evidence required for approval.