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
- SMG 1410.502 Delegations of Authority
Approval of New Animal Drug Applications, Medicated Feed Mill License Applications, and Their Supplements - 21 CFR Part 12
Formal Evidentiary Public Hearing Issuance of Notices - 21 CFR Part 514.115
Withdrawal of approval of applications - 21 CFR Part 514.116
Notice of withdrawal of approval of application - 21 CFR Part 514.200
Contents of notice of opportunity for a hearing - 21 CFR Part 514.201
Procedures for hearings