CVM 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 December 2013
- Docket Number:
- Issued by:
Guidance Issuing OfficeCenter for Veterinary Medicine
This guidance is intended for sponsors of approved applications for new animal drugs and new animal drug combination products containing medically important antimicrobial new animal drugs for use in or on medicated feed or water of food-producing animals. The guidance contains information for sponsors of such new animal drugs and combination products to facilitate voluntary changes to the conditions of use for such new animal drugs and combination products consistent with FDA’s recommendations included in the guidance document entitled “The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals” (Judicious Use Guidance, GFI #209). In particular, the purpose of this guidance is to provide sponsors with specific recommendations on how to supplement their approved new animal drug applications to align with FDA’s GFI #209.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0889.