Guidance for Industry No. 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 wi

摘要

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 FDAs 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 FDAs GFI No. 209.