FDA review data
42.6% of tracked 2015 approvals received Priority Review.
Year-by-year NDA and BLA approval mix using the FDA’s own review-priority designation.
- Priority
- 26
- Standard
- 35
- Tracked approvals
- 61
Prepared research question
What does the 2015 FDA Priority Review share: 42.6% (26 priority, 35 standard) result mean, and which assumptions matter most?
Traceable citations · Unknowns marked
| Year | Priority | Standard | Total | Priority share |
|---|---|---|---|---|
| 2026 | 12 | 25 | 37 | 32.4% |
| 2025 | 32 | 68 | 100 | 32.0% |
| 2024 | 35 | 72 | 107 | 32.7% |
| 2023 | 34 | 51 | 85 | 40.0% |
| 2022 | 28 | 50 | 78 | 35.9% |
| 2021 | 36 | 36 | 72 | 50.0% |
| 2020 | 34 | 47 | 81 | 42.0% |
| 2019 | 29 | 38 | 67 | 43.3% |
| 2018 | 42 | 49 | 91 | 46.2% |
| 2017 | 33 | 53 | 86 | 38.4% |
| 2016 | 13 | 36 | 49 | 26.5% |
| 2015 | 26 | 35 | 61 | 42.6% |
NDA and BLA approvals only, from 2015. Review priority is the FDA’s own designation on the application, not our estimate. Years with fewer than 30 tracked approvals are omitted rather than shown as a small-sample percentage.
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.
FDA’s statutory goals(the agency’s own targets under PDUFA, not measurements from our data): Standard Review targets 10 months from the filing date, and Priority Review targets 6 months. Priority Review is granted to drugs that would offer a significant improvement in safety or effectiveness over available treatments.
We publish the review-pathway mix rather than measured review durations. The actual submission-to-approval duration requires each application’s FDA receipt date, which is not exposed by any structured FDA data source — so we report what we can source rather than estimating it.
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.
From review timeline to catalyst rule
Define which FDA windows belong in your thesis
Use PDUFA timing, AdCom status, decision history, and company context as explicit event conditions—not just calendar reminders.