United States · Food and Drug Administration · New drugs
Review target
-
Not published
Legal time limit
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Not published
Steps
2
1 requirements
Application fee
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Applications for a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration must include pediatric assessments. The data must assess safety and effectiveness in all relevant pediatric age groups. Applications and supplements for a new active ingredient, indication, dosage form, dosing regimen or route.
1. Agree a pediatric study plan; 2. Include pediatric assessments in the application.
Outcome: Pediatric data in the application.
Legal basis: Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c)
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, Breakthrough therapy designation, Fast track designation, Accelerated approval, Priority review, Regenerative medicine advanced therapy designation, Orphan drug designation, National priority voucher (pilot). 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.