Source: Chris Scott, MEATINGPLACE, 10/21/15


The Food and Drug Administration (FDA) has issued what it calls a guidance document for studies aimed at evaluating the effectiveness of new animal drugs designed to reduce pathogenic Shiga toxin-producing E. Coli (STEC) in cattle.

The document provides specific suggestions for researchers who plan to execute the effectiveness tests and offers parameters for selecting animals for the studies, analyses of data and a basis for study conclusions.

The agency suggests that a protocol should be developed to specifically describe the plan for conducting an effectiveness study, including a clear statement of objectives and details about the experimental design. The document also calls for specific criteria for success, entrance and exclusions based on sound scientific principles and procedures.

The document is not designed to be a comprehensive source of information on conducting the clinical studies and asks sponsors and clinical investigators to contact the Center for Veterinary Medicine to discuss their development plan before any studies begin.

FDA also stressed that the guidance should not be seen as a comprehensive source of information on conducting clinical effectiveness studies and it also does not address the evaluation of human food safety or concerns related to antimicrobial resistance.

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