New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address

What it does

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.

The Food and Drug Administration's summary, as published in the Federal Register.

What changed in the regulation

6 parts of Title 21 of the Code of Federal Regulations:

21 CFR 516, 21 CFR 520, 21 CFR 522, 21 CFR 529, 21 CFR 556, 21 CFR 558

Wording on eCFR: the day before it took effect and from the day it took effect (first part listed).

Compared with

The Food and Drug Administration has published 103 final rules in 2026 so far, compared with 68 in all of 2025.

Counted by the Tribune from Federal Register records since Jan. 1, 2025.

What happens next and when

This rule is effective February 6, 2026.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2025-N-0002 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register