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FDA's Center for Veterinary Medicine (CVM) received a letter requesting a response to several issues related to the use of fluoroquinolone drug products for treating disease in food-producing animals. This 9/16/97 letter from major producer organizations, the Animal Health Institute, the American Association of Swine Practitioners, and the American Veterinary Medical Association requested that CVM:
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Continue to approve new fluoroquinolones for food animals based on the 1994 recommendations of the Joint CVM Advisory Committee, and not based on reports of certain food borne outbreaks whose relationship to antibiotic use in animals is unsubstantiated.
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Explain the scientific rationale for FDA's current thinking on fluoroquinolone use in animals by responding in detail to comments filed to the docket pertaining to the extra label use of these products.
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Provide clear guidance to sponsors as to how this may affect their future research and development plans for new antibacterials as well as to producers and veterinarians in need of new therapeutic antibacterials.
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Release the draft risk assessment the Center has so far prepared on fluoroquinolones to allow other scientists to assist with filling data gaps which may be preventing completion.
CVM responded to these concerns in a February 10, 1998, letter.
Web Page Updated by - Friday, June 30, 2000 at 9:12 AM ET
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