🐶Correction to Animal Drug Regulations
New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address; Correction
Summary
The Food and Drug Administration (FDA or we) is correcting a final rule entitled "New Animal Drugs; Approval of New Animal Drug Applications; Withdrawal of Approval of New Animal Drug Applications; Change of Sponsor; Change of Sponsor Address" that appeared in the Federal Register of August 22, 2025. That final rule updated regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during April, May, and June of 2025. The final rule published with an inadvertent error. This document corrects that error.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory text outlines corrections related to the approval process of new animal drugs, which directly affects compliance and regulatory requirements for businesses in the animal pharmaceutical industry. The potential for errors in official documents can impact companies manufacturing or distributing these drugs by creating compliance challenges.