Health Law Daily Wrap Up, ADMINISTRATION OF FDC ACT—FINAL RULES: Withdrawal of approval of new animal drug application, (Apr 17, 2026)
By WK Editorial Staff
Although deemed a rule under the FDC Act, the document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability” and is not subject to the congressional review requirements in 5 U.S.C. 801—808.
The FDA 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. The final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). The rule is not subject to Executive Order 12866 (Final Rule, 91 Fed. Reg. 20337 (Apr. 16, 2026)).
Dates. This rule is effective April 16, 2026.
FederalRegisterIssuances: FinalRules FDCActNews DrugBiologicNews