9 May 2025
🐾FDA Final Rule on New Animal Drug Regulations Effective May 2025
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor
Summary
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory changes involve compliance requirements for businesses involved in the approval and marketing of new animal drugs. The amendments affect application processes and sponsor changes, which may require adjustments to business operations for affected companies.