New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
other · Food and Drug Administration · Rule · Published 2026-02-06 · Effective 2026-02-06 · 91 FR 5299
Document
Document number
2026-02331
Federal Register citation
91 FR 5299
CFR reference
21 CFR 516
Type
Rule
Action
Final rule; technical amendments.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2026-02-06
Effective date
2026-02-06
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 July, August, and September 2025. The animal drug regulations are also being amended to improve their accuracy and readability.