Data / Federal rules / 2026-07500
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
The Food and Drug Administration published this final rule in the Federal Register on April 16, 2026. It took effect on April 16, 2026.
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What the agency says
The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditionally approved new animal drug applications (CNADAs) during October, November, and December 2025. The animal drug regulations are also being amended to improve their accuracy and readability.
Key facts
- Document number
- 2026-07500
- Type
- Final rule
- Action
- Final rule; technical amendments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- April 16, 2026
- Takes effect
- April 16, 2026
- Dates
- This rule is effective April 16, 2026.
- Docket
- Docket No. FDA-2025-N-0002
- Code of Federal Regulations
- 21 CFR 510; 21 CFR 516; 21 CFR 520; 21 CFR 522; 21 CFR 524; 21 CFR 558
- Topics
- Administrative practice and procedure; Animal drugs; Confidential business information; Labeling; Reporting and recordkeeping requirements
- Pages
- 12
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on administrative practice and procedure · Rules on animal drugs · Rules on confidential business information · Published in April 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.