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GUIDANCE DOCUMENT

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

Final

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

Docket Number:
FDA-2011-D-0889
Issued by:
Guidance Issuing Office
Center 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.


Submit Comments

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:

Division of Dockets Management (HFA- 305)
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.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
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Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002