United States · Food and Drug Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
-
A pilot program announced in June 2025. A voucher gives a much faster review target, about 1 to 2 months, for a product that fits one of five national health priorities. Approval standards stay the same. Vouchers cannot be transferred. Drug and biological product applications that match a national health priority, such as unmet need, affordability or domestic manufacturing.
1. Ask for a voucher; 2. Team review with a senior review council; 3. Decision by the product center.
Outcome: A voucher that gives enhanced communication, rolling review and a shorter review target.
Legal basis: Agency pilot program
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 61 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, Breakthrough therapy designation, Fast track designation, Accelerated approval, Priority review, Regenerative medicine advanced therapy designation, Orphan drug designation, 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 (6 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.