United States · Food and Drug Administration · Cell and gene therapy
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
1 requirements
Application fee
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A designation for regenerative medicine therapies, such as cell therapies, that treat serious or life-threatening conditions and show early clinical potential to address unmet needs. It gives access to expedited development and review. Cell therapies and other regenerative medicine therapies for serious conditions.
1. Request the designation; 2. Decision on the request (60 days).
Outcome: Designation, or a decision that the criteria are not met.
Legal basis: Section 506(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(g))
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: Biosimilar application (351(k)), Biologics license application (351(a)), Breakthrough therapy designation, Fast track designation, Accelerated approval, Priority review, Orphan drug designation, National priority voucher (pilot), Emergency use authorization, Expanded access (compassionate use), Pediatric study requirements. See all routes on the United States page or explore them in the Regulatory section.
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.