United States · Food and Drug Administration · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
3
2 requirements
Application fee
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A designation for drugs and biologics for serious or life-threatening conditions when early clinical evidence suggests substantial improvement over existing therapies. It brings more meetings, timely advice and involvement of senior staff during development. Serious or life-threatening conditions with promising early clinical results.
1. Request the designation; 2. Decision on the request (60 days); 3. Intensive guidance during development.
Outcome: Designation, or a decision that the criteria are not met.
Legal basis: Section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a))
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 60 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
| 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, Fast track designation, Accelerated approval, Priority review, Regenerative medicine advanced therapy designation, Orphan drug designation, National priority voucher (pilot), Emergency use authorization. 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.