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 Guidance for Industry #209; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 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 Guidance for Industry 209." The purpose of this document is to provide information to sponsors of certain antimicrobial new animal drug products who are interested in revising conditions of use for those products consistent with FDA's Guidance for Industry (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.