FDA Approval Timelines
Historical FDA drug review durations by review pathway. Understand how long each type of review typically takes from submission to decision.
Priority Review
1 decision in database
243
avg. days
Priority Review for drugs that offer significant improvements. Reduces review time to 6 months from submission.
Standard Review
1 decision in database
57
avg. days
Standard review for drugs that offer minor improvements over existing treatments. The FDA target is 10 months from submission.
Understanding FDA Review Pathways
The FDA offers several expedited programs to speed up drug development and review. The review pathway is a critical factor for biotech investors, as it directly impacts the timeline from NDA/BLA submission to potential approval.
Key Dates for Investors
- PDUFA Date: The target date by which the FDA will complete its review. This is the most-watched catalyst in biotech investing.
- Advisory Committee: FDA may convene an expert panel (AdCom) before the PDUFA date. The vote, while non-binding, predicts approval 75-80% of the time.
- Complete Response Letter (CRL): If the FDA determines the application is not ready for approval, it issues a CRL outlining deficiencies.
Never miss a PDUFA date
BioSniper tracks every upcoming PDUFA date, AdCom meeting, and FDA decision across 1,500+ biotech companies.