FDA Issues Planned Guidance for 2015

The Center for Veterinary Medicine outlines the regulatory advice it may issue to the drug industry this year.

The Center for Veterinary Medicine does not regulate animal vaccines. That responsibility lies with the U.S. Department of Agriculture.


As many as 31 new or updated documents that would help veterinary drug manufacturers and other stakeholders meet the expectations of federal regulators may be released this year.

The U.S. Food and Drug Administration’s Center for Veterinary Medicine last week circulated a list of topics that may be addressed in draft form or as final guidance. The nonbinding documents would explain the agency’s interpretation of a regulatory issue or its policy and in many cases would steer stakeholders toward meeting regulatory goals.

FDA issues more than 100 guidances each year to industries under its jurisdiction.

The Center for Veterinary Medicine’s tentative list for 2015 includes:

  • Draft Guidance for Industry: Compounding Animal Drugs from Bulk Drug Substances
  • Guidance for Industry (GFI #61): FDA Approval of Animal Drugs for Minor Uses and for Minor Species (Revision)
  • Draft Guidance for Industry: Combination New Animal Drugs
  • Guidance for Industry (GFI #218): Cell-Based Products for Use in Animals
  • Draft Guidance for Industry: Medicated Feed Assays
  • Guidance for Industry (GFI #116): Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing—VICH GL23(R)
  • Draft Guidance for Industry: Proprietary Names on Drug Labeling
  • Draft Guidance for Industry: Design and Submission of Distributor Labeling
  • Guidance for Industry (GFI #220): Use of Nanomaterials in Food for Animals

The complete list is available at http://1.usa.gov/1LFkk1q.

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