Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals; Guidance for Industry; Availability

Короткий зміст

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #273 entitled "Defining Durations of Use for Approved Medically Important Antimicrobial Drugs Fed to Food-Producing Animals." This guidance document provides recommendations on how sponsors may voluntarily establish defined durations of use for certain antimicrobial new animal drugs used in or on the medicated feed of food-producing animals that are currently approved with one or more indications that lack a defined duration of use. Establishing defined durations of use within the approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) is intended to mitigate development of antimicrobial resistance for these antimicrobial drugs, which are important to human medicine. It also proposes timelines for sponsors to voluntarily align their affected applications with this guidance.