United States · Food and Drug Administration · Biologics
Review target
304 days
performance goal
Legal time limit
-
Not published
Steps
5
5 requirements
Application fee
$4,600,753
FY2027
The route for new biological products, including vaccines and cell and gene therapies. The license is based on showing that the product is safe, pure and potent, and that the facility meets standards. The agency can require that each lot is released by it before distribution. New biological products such as therapeutic proteins, vaccines, and cell and gene therapy products.
The official review target is 304 days (performance goal, met in 90% of cases). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The application fee, application requiring clinical data is $4,600,753 for FY2027.
1. Send the application; 2. Filing review (60 days); 3. Review (304 days); 4. Decision; 5. Lot release (when required).
Outcome: A biologics license, or a complete response letter.
Legal basis: Section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)); 21 CFR Parts 600 to 680
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 364 days end to end with the official step targets. Targets, not actual times.
From the official approvals data of this market, all products of this pathway type and segment
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Review targetperformance goal, met in 90% of cases. About 10 months after the 60-day filing date, for 90 percent of standard original applications. This is an official target, not an actual review time. | 304 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Application fee, application requiring clinical dataApplication · FY2027 · A small business can get a waiver for its first application. | $4,600,753 |
Other routes in United States: Biosimilar application (351(k)), Breakthrough therapy designation, Fast track designation, Accelerated approval, Priority review, Regenerative medicine advanced therapy designation, 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 (11 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.