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Genetically Modified Food, Nanomaterials among Topics Addressed in Planned 2013 CVM Guidances

Posted 19 March 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has announced guidance documents its Center for Veterinary Medicines (CVM) plans to publish by the end of the 2013 calendar year, including several topics that could be harbingers for the rest of the pharmaceutical industry.

The publication of the guidance list follows similar publications of documents for medical device and pharmaceutical products, and includes a number of important guidance documents.

Of note:

Draft Guidance for Industry - Use of Nanomaterials in Food for Animals (#24), which would represent the latest nanomaterials guidance for FDA, which released similar guidance for human food and cosmetic products for the first time in 2012, raising the prospect that similar guidance for medicines could soon be on the way.

Another guidance (draft) (#3) being considered would set into place better coordination of the regulatory process by which genetically engineered animals could come to market for human consumption. The first animal, a GE salmon, recently passed preliminary FDA review, though the agency continues to receive a flurry of negative comments from the general public and even some members of Congress.

The animal equivalence of the orphan drug act would also see some new guidance, with FDA looking to revise its minor uses and minor species (MUMS) guidance (#4).

Other guidance documents of interest include a draft guidance regarding the use of cell-based products for use in animals (#15), the presence of antibiotic residues in animal food (#15) and pharmacovigilance practices for veterinary medicines (#25).

The full list of 25 draft and final guidance documents may be found below.

CVM Planned Guidance Documents for 2013

1.) Draft Guidance for Industry - Marketed Unapproved New Animal Drugs

2.) Guidance For Industry (GFI #213) - New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209

3.) Draft Guidance for Industry - Inter-Center Coordination of the Regulatory Requirements for the Development of Genetically Engineered (GE) Animals for the Production of Human-Use Products

4.) Guidance For Industry (GFI #61) - FDA Approval of Animal Drugs for Minor Uses and for Minor Species (Revision)

5.) Draft Guidance for Industry (GFI #210) - The Indexing of Legally Marketed Unapproved New Animal Drugs for Minor Species

6.) Draft Guidance for Industry - Combination New Animal Drugs

7.) Draft Guidance for Industry - Presenting and Analyzing Target Animal Safety Study Data

8.) Draft Guidance for Industry - Medicated Feed Assays

9.) Draft Guidance for Industry - Question-Based Review for Animal Drugs

10.) Draft Guidance for Industry -CMC Guidances for Generic New Animal Drugs

11.) Guidance for Industry (GFI #23) - Medicated Free Choice Feeds (Revision)

12.) Draft Guidance for Industry (GFI #57) - Preparation and Submission of Veterinary Master Files (Revision)

13.) Guidance for Industry (GFI #171) - Waivers of In Vivo Demonstration (Revision)

14.) Guidance for Industry (GFI #204) - Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals

15.) Draft Guidance for Industry (GFI #218) - Cell-Based Products for Use in Animals

16.) Guidance for Industry (GFI #219) - Statistical Evaluation of Stability Data - VICH GL51(R)

17.) Guidance for Industry (GFI #188) - Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine

18.) Draft Guidance for Industry (GFI #203) - Ensuring Safety of Animal Food Maintained and Fed On-Farm

19.) Draft Guidance for Industry (GFI #221) - Recommendations for Preparation and Submission of Animal Food Additive Petitions

20.) Draft Guidance for Industry (GFI #222) - Antibiotic Residues in Distiller's Grains Used as Animal Food

21.) Compliance Policy Guide - Salmonella Contamination of Feeds

22.) Draft Guidance for Industry - Design and Submission of Distributor Labeling

23.) Guidance for Industry - Declaring Color Additives in Animal Foods Small Entities Compliance Guide (SECG)

24.) Draft Guidance for Industry - Use of Nanomaterials in Food for Animals

25.) Guidance for Industry (GFI #214) - Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data - VICH GL35(R)

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