Definition
Priority Review is an FDA designation that sets a goal for FDA to complete its review within 6 months, compared to the standard 10-month timeline. Priority Review is granted to drugs that would provide significant improvements in treatment, diagnosis, or prevention of serious conditions.
How Priority Review Works
Sponsors request Priority Review at NDA or BLA submission. FDA determines eligibility within 45 days based on whether the drug represents a significant improvement over available therapy.
Eligibility Criteria
- Significant improvement in safety or effectiveness
- Treatment, diagnosis, or prevention of serious condition
- Compared to available therapy (not placebo)
- Request made at application submission
Priority vs Standard Review
| Aspect | Priority Review | Standard Review |
|---|---|---|
| Review Goal | 6 months | 10 months |
| Eligibility | Significant improvement | All other applications |
| Determination | Within 45 days | Default |
| Common For | Novel mechanisms, unmet needs | Most applications |
Priority Review Statistics
Approximately 40-50% of novel drug approvals receive Priority Review designation. The median actual review time for Priority Review is around 8 months.
Why BD Teams Track Priority Review
For business development professionals, Priority Review accelerates timeline:
- Deal Implication: Priority Review can shave 4 months off timeline, affecting deal terms and milestone timing
- Due Diligence Focus: Verify Priority Review status and understand FDA’s rationale for granting it
- Opportunity Signal: Priority Review designation indicates FDA recognizes meaningful advancement