This guidance describes principles for designing, conducting, and reporting the results for investigations or studies including biomarkers and/or surrogate endpoints to demonstrate substantial evidence of effectiveness or a reasonable expectation of effectiveness of drugs intended for use in animals and to support the approval of a new animal drug application (NADA) or an application for conditional approval of a new animal drug (CNADA). This guidance also provides information about obtaining feedback from CVM with respect to incorporating biomarkers and/or surrogate endpoints in investigations and study protocols for new animal drugs.    

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