United States · Food and Drug Administration · New drugs
Review target
304 days
performance goal
Legal time limit
-
Not published
Steps
4
5 requirements
Application fee
$2,300,376
FY2027
A new drug application that relies in part on studies that were not run by or for the applicant, and that the applicant has no right to use. The applicant adds its own data to bridge to that evidence and certifies the status of the related patents. When part of the evidence comes from studies the applicant did not run and has no right to use.
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 not requiring clinical data is $2,300,376 for FY2027.
1. Send the application; 2. Filing review (60 days); 3. Scientific review (304 days); 4. Decision.
Outcome: Approval letter or complete response letter.
Legal basis: Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; 21 CFR Part 314
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 from receipt for 90 percent of standard applications. This is an official target, not an actual review time. | 304 days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Application fee, application not requiring clinical dataApplication · FY2027 · Applications that need clinical data pay the full clinical-data fee. | $2,300,376 |
Other routes in United States: New drug application (full, new active ingredient), Abbreviated new drug application (generic), Over-the-counter monograph order, Prescription to nonprescription switch, 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.