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GUIDANCE DOCUMENT

CVM GFI #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs July 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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


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.    

Questions?

Contact Point
Susan Storey
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-131
Rockville, MD 20855
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