FDAFinal Rule
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Application; Change of Sponsor; Change of Sponsor Address
AgricultureHealthcare
Ad Space (leaderboard)
Summary
This FDA regulation sets the rules for how new medicines for animals get approved, taken off the market, or transferred between companies. It matters to pet owners, farmers, and livestock producers because it ensures animal medications are safe and effective before being used.
Key Points
- 1The FDA establishes the process for approving new drugs intended for animals, including what companies must prove about safety and effectiveness
- 2The regulation allows the FDA to withdraw approval of animal drugs that are found to be unsafe or no longer meet safety standards
- 3Companies can transfer ownership of approved animal drug applications to other companies, but the FDA must be notified and approve the change
- 4Companies must update the FDA if they change their address or other important contact information for their animal drug applications
- 5These rules apply to all new animal drugs, whether used for pets, farm animals, or other animals in the United States
Key Dates
Published
February 6, 2026
This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.
The Digest Network
Ad Space (rectangle)