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                Recalls & Withdrawals

Recalls & Withdrawals

                        Melamine Pet Food Recall of 2007
          Process for Withdrawal of Approval of a New Animal Drug Application
          Withdrawal of Enrofloxacin for Poultry Home
          Animal & Veterinary
          Safety & Health
          Recalls & Withdrawals
          Process for Withdrawal of Approval of a New Animal Drug ApplicationRecalls & Withdrawals Process for Withdrawal of Approval of a New Animal Drug Application
  
  	
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    PrintThe 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

FD&C Act Chapter V: Drugs and DevicesTitle 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
	Animal drugs.
	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.CVM Program Policy and Procedures Manual

1240.3670 Management of Formal Evidentiary HearingsAdditional Information

New Animal Drug Applications

                                                                                  Content current as of:
      05/04/2023Recalls & Withdrawals

          
                        Melamine Pet Food Recall of 2007
          Process for Withdrawal of Approval of a New Animal Drug Application
          Withdrawal of Enrofloxacin for Poultry
 
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