Draft Guidance for Industry on New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: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; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (draft GFI 213) entitled "New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of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." The purpose of this document is to provide information to sponsors of certain new animal drug products who are interested in developing revised conditions of use for those products consistent with FDA's GFI 209, "The Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals" and to set timelines for stakeholders wishing to comply voluntarily with this guidance.