Definition
Priority Review
Priority review is an FDA designation that sets a six-month goal for acting on a marketing application, instead of the standard ten months, for drugs and biologics that would significantly improve the treatment, diagnosis or prevention of a serious condition.
1 min readReviewed September 14, 2026
Also known as: Priority review designation, Six-month review, Priority review voucher
Key facts
- Review goal
- 6 months, vs 10 months for standard review
- Clock for new molecular entities
- Starts at the 60-day filing date, about 8 months from submission
- Created under
- Prescription Drug User Fee Act of 1992 (PDUFA)
- Decided
- By the FDA at filing, within 60 days of submission
What is priority review?
Priority review changes how fast the FDA aims to act, not what evidence it requires. An application under priority review must meet the same approval standards as any other, but under its user fee commitments the agency aims to reach a decision in six months instead of ten.
The FDA decides whether to grant priority review when it files the application. Sponsors can request it, and some products receive it by law, such as drugs designated as qualified infectious disease products under the GAIN Act.
How the review clock works
Goal dates depend on the application type:
- New molecular entity NDAs and original BLAs: the clock starts at the 60-day filing date, so priority review targets about 8 months and standard review about 12 months from submission.
- Other original applications: 6 months for priority and 10 months for standard review, counted from receipt.
- A major amendment submitted during review can extend the goal date by three months.
- Goal dates are performance targets: the FDA meets most of them, but it can act early or miss one.
Why priority review matters
The user fee goal date, often called the PDUFA date, is one of the most watched events in biopharma. Launch planning, supply builds and investor expectations are set against it, and priority review can pull a decision forward by four months.
Congress also created priority review vouchers, which a sponsor can earn by winning approval for a qualifying product, such as a treatment for a tropical disease, and then redeem for a different application or sell to another company. Some voucher programs, including the rare pediatric disease program, have faced sunset deadlines, so check their current status before relying on them.