Data / Federal rules / 2025-18217
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
The Food and Drug Administration published this final rule in the Federal Register on September 19, 2025. It took effect on September 19, 2025.
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What the agency says
The Food and Drug Administration (FDA or we) is correcting a final rule entitled "New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address" that appeared in the Federal Register of August 22, 2025. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June of 2025. The final rule published with an inadvertent error. This document corrects that error.
Key facts
- Document number
- 2025-18217
- Type
- Final rule
- Action
- Final rule; correction
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- September 19, 2025
- Takes effect
- September 19, 2025
- Dates
- This rule is effective September 19, 2025.
- Docket
- Docket No. FDA-2025-N-0002
- Code of Federal Regulations
- 21 CFR 558
- Pages
- 1
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Published in September 2025
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.