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GUIDANCE DOCUMENT

CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs October 2021

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2020-D-1402
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

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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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-1402.

Questions?

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CVM
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Food and Drug Administration
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Rockville, MD 20855
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