New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
other · Food and Drug Administration · Rule · Published 2025-05-09 · Effective 2025-05-09 · 90 FR 19623
Document
Document number
2025-08137
Federal Register citation
90 FR 19623
CFR reference
21 CFR 510
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2025-05-09
Effective date
2025-05-09
HHS docket
Docket No. FDA-2025-N-0002
Abstract
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 January, February, and March 2025. The animal drug regulations are also being amended to improve their accuracy and readability.