The U.S. Food and Drug Administration released a draft guidance for industry to provide recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved medically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.
As of Sept. 25, there are nearly 100 approved animal drug applications for medically important antimicrobials…