The US Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) recently issued its fourth progress report outlining its actions promoting the judicious use of antimicrobials in livestock. The report, titled “Guidance for Industry 213 in December of 2013” focuses on reducing the use of medically important antimicrobials administered through feed, particularly those used to improve animal performance, and to bring other uses of those products under the oversight of veterinarians. The guidance calls on drug sponsors, by December 2016, to voluntarily remove indications for use related to growth promotion from product labels of medically important feed-grade antimicrobials. According to the FDA/CVM, 293 applications were initially affected by Guidance 213. All of the affected drug sponsors have indicated that they intend to comply with the voluntary guidance by the December deadline, and some already have begun implementing the recommended changes. Three applications have been converted from over-the-counter to prescription dispensing status, production indications have been withdrawn from one application and 35 affected applications have been completely withdrawn. For more information click HERE.
Published on Mon, 8th Feb 2016 - 20:49