United States · Food and Drug Administration · New drugs
Review target
304 days
performance goal
Legal time limit
180 days
regulation
Steps
7
7 requirements
Application fee
$4,600,753
FY2027
The standard route for a new medicine. The company sends a full application with its own clinical and nonclinical studies and manufacturing data. The agency first checks whether the file can be accepted, then reviews it and either approves it or sends a complete response letter that lists the problems. A drug with a new active ingredient, supported by the applicant's own studies.
The official review target is 304 days (performance goal, met in 90% of cases). The legal time limit is 180 days. 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. Pre-submission meetings (optional); 2. Send the application; 3. Filing review (60 days); 4. Scientific review (304 days); 5. Major amendment (if sent) (91 days); 6. Decision; 7. Post-approval duties.
Outcome: Approval letter, or a complete response letter that lists what must be fixed.
Legal basis: Section 505(b) 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 455 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
| Validationregulation. Filing decision. | 60 days |
| Legal time limitregulation. The regulation sets a 180-day initial review cycle, which can be adjusted by agreement or after a major amendment. | 180 days |
| Review targetperformance goal, met in 90% of cases. About 10 months after the 60-day filing date, 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 requiring clinical dataApplication · FY2027 · A small business (fewer than 500 employees, including affiliates) can get a waiver for its first application. | $4,600,753 |
Other routes in United States: New drug application relying on other data (505(b)(2)), 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 (20 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.