FDA Releases Draft Guidance on Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food Animals

Today, the U.S. Food and Drug Administration released a draft guidance for industry (GFI) to provide recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved medically important antimicrobial animal drugs with indications that currently lack a defined duration of use.

When a drug lacks a defined duration of use, it means the labeling does not include information about how long a product can be administered for an approved indication.