Issue Date: October 6, 2021
Issued by: Center for Veterinary Medicine
Topic(s): Premarket, Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), Target Animal – Effectiveness
Status: Final
CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs
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.
Download the Guidance Document
