United States · Food and Drug Administration · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
4
3 requirements
Application fee
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Approval for a serious or life-threatening condition based on an effect on a surrogate endpoint, or an intermediate clinical endpoint, that is reasonably likely to predict clinical benefit. Confirmatory studies are required, and the agency can require them to be underway before approval. Approval can be withdrawn through an expedited procedure. Serious conditions where a surrogate endpoint can predict benefit and there is an unmet need.
1. Agree on endpoints and confirmatory study; 2. Accelerated approval; 3. Confirmatory study; 4. Benefit verified, or approval withdrawn.
Outcome: Approval with a duty to confirm clinical benefit.
Legal basis: Section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c)); 21 CFR 314 Subpart H and 601 Subpart E
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).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
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, Priority review, 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.