U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion

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

About this resource:

HHS Non-systematic Review

Source: Food and Drug Administration, 2013

Last Reviewed: August 2018

Workgroups: Food Safety Workgroup

This webpage gives an overview of guidance around new animal drug and drug products. Specifically, the guidance has information for sponsors of approved applications about updating their applications to align with the U.S. Food and Drug Administration’s recommendations on using medically important antimicrobial drugs in food-producing animals. It also includes links to:

  • The federal register notice
  • Full guidance document
  • Public comments on the guidance
Read more about this resource

Objectives related to this resource (2)

Prevent an increase in the proportion of nontyphoidal Salmonella infections that are resistant to multiple drug classes — FS‑05
Baseline only
Prevent an increase in the proportion of macrolide antibiotic-resistant Campylobacter infections — FS‑06
Baseline only

Suggested Citation

1.

Center for Veterinary Medicine, U.S. Food and Drug Administration. (2013). 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. Retrieved from https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-213-new-animal-drugs-and-new-animal-drug-combination-products-administered-or-medicated-feed