Process for Withdrawal of Approval of a New Animal Drug Application
The Center for Veterinary Medicine shall propose to withdraw approval of new animal drug applications (NADAs) based on findings regarding the safety or effectiveness of the drug product. CVM may also propose to withdraw approval of NADAs for deficiencies in required records, manufacturing, and labeling. 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
- 21 CFR 25.33
- 21 CFR 514.115
Withdrawal of approval of applications.
- 21 CFR 514.116
Notice of withdrawal of approval of application.
- 21 CFR 514.200
Notice of opportunity for hearing; notice of participation and requests for hearing; grant or denial of hearing.
- 21 CFR 514.201
Procedures for hearings.