The Food and Drug Administration has announced the availability of a draft guidance entitled “Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals.” The draft guidance, when finalized, is intended to provide guidance to industry for designing and conducting clinical effectiveness studies and describes criteria that the Center for Veterinary Medicine believes are the most appropriate for the evaluation of the effectiveness of anticoccidial drugs intended for use in poultry and other food-producing animals.

Comments of the draft guidance must be submitted  no later than January 23 to ensure that the agency considers comments before it begins work on the final version of the guidance.  Electronic comments may be submitted at www.regulations.gov.  Written comments should be submitted to the Division of Dockets Management (HFA 395), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD  20852.  The draft guidance is available by clicking  here.

 

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