Submission & Approval

Priority Review(Priority)

An FDA designation that reduces the review time for drugs treating serious conditions and providing significant improvement over available therapy.

Usage Examples

The NDA received Priority Review based on improved survival data.
Priority Review reduced the expected approval timeline by 4 months.
FDA granted Priority Review for the novel oncology treatment.

What is Priority?

Priority Review is an FDA designation that shortens the target review time from the standard 10 months to 6 months. It's granted to drugs that offer significant improvements in safety or effectiveness for treating, diagnosing, or preventing serious conditions.

Priority Review does not change the scientific standards for approval or the data required for submission. It simply commits FDA to a faster review timeline. The designation is determined after the application is submitted, typically at the 60-day filing decision.

This is distinct from other expedited programs like Fast Track, Breakthrough Therapy, and Accelerated Approval, though drugs may receive multiple designations.

Regulatory Context

This term appears most often in submission & approval workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside PDUFA, 21 CFR 314.

FDAICHEMA

When This Matters

The NDA received Priority Review based on improved survival data.
Priority Review reduced the expected approval timeline by 4 months.
FDA granted Priority Review for the novel oncology treatment.

Common Mistakes

Treating submission readiness as a formatting-only check without lifecycle validation.
Using outdated guidance references across modules and summaries.
Missing cross-functional review between RA, CMC, and quality before submission.

Related Regulations

PDUFA21 CFR 314

Frequently Asked Questions

Priority Review is granted for drugs offering significant improvements over existing therapies for serious conditions. The improvement can be in effectiveness, safety, or reduced burden of treatment.

No. Fast Track provides earlier and more frequent FDA interactions during development. Priority Review only shortens the NDA/BLA review time. A drug may receive both designations.