October 15, 2002


 FDA seeks comments on evaluating antimicrobial animal drugs guidance

Posted Oct. 1, 2002

The Food and Drug Administration announced on Sept. 11 the availability of a draft guidance document "Guidance for the Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern" for public comment.

The guidance provides a recommended approach for assessing the safety of food animal antimicrobial drugs, focusing on the effects of the drugs on bacteria that may pose a threat to human health. It also discusses possible risk management strategies. The guidance is designed to be a part of the overall preapproval safety evaluation of new animal drugs. The full document is available at www.fda.gov/OHRMS/DOCKETS/98fr/98d-1146-gdl0001.doc.

Public comments can be submitted to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The deadline for comments is Nov. 27.

FDA officials are concerned that using antimicrobial drugs in food animals may lead to the emergence of bacterial pathogens that are drug resistant and potentially harmful to humans.