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Animal & Veterinary
Withdrawal of New Animal Drug Application Process
The Center for Veterinary Medicine has had to propose the withdrawal of approval of new animal drug applications on the issue of the safety and effectiveness of the drug. The applicable statutes, regulations and policies for the withdrawal process are listed here.
Applicable Statutes, Regulations and Policies
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U.S. Code - Title 21 - Food and Drugs
- Part 5.502 (TXT - 2KB)
Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications - Part 12 (TXT - 72KB)
Formal Evidentiary Public Hearing Issuance of Notices - 514.115 (TXT - 6KB)
Withdrawal of approval of applications - 514.116 (TXT - 1KB)
Notice of withdrawal of approval of application - 514.200 (TXT - 4KB)
Contents of notice of opportunity for a hearing - 514.201 (TXT - 1KB)
Procedures for hearings
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CVM Program Policy and Procedures Manual
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