FDA issues animal drug guidance.

The U.S. FDA has issued first-ever guidelines for assessing the safety of antimicrobial drugs used in food-producing animals with regards to microbial resistance in the humans who eat them. The guidance centers on a three-part, evidence-based scientific risk assessment process for integrating relevant information into an overall estimate of the likelihood that any given antimicrobial used for veterinary purposes will cause resistance in human consumers. The assessment is not mandatory, but instead offers drug manufacturers one alternative for demonstrating to the FDA during the drug approval process that their products do not contribute to microbial resistance in humans.