United States · Food and Drug Administration · New drugs
Review target
183 days
performance goal
Legal time limit
-
Not published
Steps
3
1 requirements
Application fee
-
With priority review, the agency's goal is to act on the application in 6 months instead of 10. For a new molecular entity or an original biologics license application, the 6 months run from the 60-day filing date. Applications for drugs that could bring a significant improvement for a serious condition.
The official review target is 183 days (performance goal, met in 90% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Application sent; 2. Priority review (183 days); 3. Decision.
Outcome: A shorter review goal.
Legal basis: Prescription drug user fee performance goals
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 183 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal, met in 90% of cases. About 6 months after the 60-day filing date for new molecular entities and original licenses. This is an official target, not an actual review time. | 183 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in United States: New drug application (full, new active ingredient), New drug application relying on other data (505(b)(2)), Abbreviated new drug application (generic), Biosimilar application (351(k)), Biologics license application (351(a)), Over-the-counter monograph order, Prescription to nonprescription switch, Breakthrough therapy designation, Fast track designation, Accelerated approval, Regenerative medicine advanced therapy designation, Orphan drug designation, National priority voucher (pilot), . See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (4 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.