Draft Guidance for Industry on Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry 217 entitled "Evaluating the Effectiveness of Anticoccidial Drugs in Food-Producing Animals." The draft guidance, when finalized, is intended to provide guidance to industry for designing and conducting clinical effectiveness studies, and describes criteria that the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 (CVM) thinks are the most appropriate for the evaluation of the effectiveness of anticoccidial drugs intended for use in poultry and other food-producing animals. The draft guidance also suggests times during the evaluation of effectiveness when sponsors may wish to consult with CVM.