Definition
PDUFA Date is the target date by which FDA aims to complete review of an NDA or BLA, established under the Prescription Drug User Fee Act. Standard review has a 10-month goal; Priority Review has a 6-month goal from the filing date.
How PDUFA Dates Work
Upon filing an application, FDA sets the PDUFA date based on review type. Sponsors pay user fees to support FDA’s review capacity and timeline commitments.
PDUFA Timeline
| Review Type | Timeline | From |
|---|---|---|
| Standard Review | 10 months | Filing date (Day 60) |
| Priority Review | 6 months | Filing date (Day 60) |
| Resubmission (Class 1) | 2 months | Resubmission date |
| Resubmission (Class 2) | 6 months | Resubmission date |
PDUFA Date Outcomes
| Outcome | Description |
|---|---|
| Approval Letter | Drug approved for marketing |
| Complete Response Letter | Cannot approve as submitted |
| 3-Month Extension | Major amendment late in review |
| Tentative Approval | Approved but blocked by exclusivity |
Why BD Teams Track PDUFA Dates
For business development professionals, PDUFA dates are critical milestones:
- Deal Implication: PDUFA dates trigger milestone payments and affect deal timing
- Due Diligence Focus: Monitor PDUFA dates for competitive products and portfolio assets
- Opportunity Signal: Approaching PDUFA dates create decision points for licensing or M&A