Table of Contents

Withdrawal
Enrofloxacin for Poultry

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

• Federal Food, Drug and Cosmetic Act, As Amended -- Chapter V - Drugs and Devices

• Subchapter A- Drugs and Devices Section 512 [360b]

• U.S. Code: Title 21 - Food and Drugs

• Part 5.502 – Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications

• Part 12 – Formal Evidentiary Public Hearing Issuance of Notices

• 514.115 – Withdrawal of approval of applications

• 514.116 – Notice of withdrawal of approval of application

• 514.200 – Contents of notice of opportunity for a hearing

• 514.201 – Procedures for hearings

• CVM Program Policy and Procedures Manual

• Guide 1240.3670 - Management of Formal Evidentiary Hearings

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