United States · Food and Drug Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
2 requirements
Application fee
-
During a declared emergency, the agency can authorize an unapproved product, or an unapproved use, when it is reasonable to believe the product may be effective and there is no adequate, approved and available alternative. Only while an emergency declaration is in effect.
1. Emergency declaration in effect; 2. Request for authorization; 3. Authorization decision.
Outcome: An authorization limited to the emergency.
Legal basis: Section 564 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb-3)
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, Premarket notification (510(k)), De Novo classification request, Premarket approval (PMA), Humanitarian device exemption, Class I devices exempt from premarket notification, Software as a medical device: how it is regulated. 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 (3 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.