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Process for Withdrawal of Approval of a New Animal Drug Application

Process for Withdrawal of Approval of a New Animal Drug Application

The Center for Veterinary Medicine shall propose the withdrawal of approval of new animal drug applications (NADAs) for issues of the safety or effectiveness of the drug product. It may also propose the withdrawal of approval of NADAs on issues of required records, manufacturing, and labeling deficiencies. However, the majority of withdrawal actions are voluntary requests by an application sponsor because the animal drug product is no longer manufactured or marketed. The applicable statutes, regulations, and policies for the withdrawal process are listed here.

Applicable Statutes, Regulations and Policies

Federal Food, Drug and Cosmetic Act, As Amended

Title 21 - Food and Drugs

 CVM Program Policy and Procedures Manual

Additional Information