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GUIDANCE DOCUMENT

CVM GFI #287 - Raw Data for Safety and Effectiveness Studies April 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-1613
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance provides recommendations to sponsors on submission of raw data.  In addition, this guidance discusses how CVM uses the raw data during review of new animal drug applications and how the raw data allows CVM to have confidence in the information used to make regulatory decisions.

Submit Comments

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-2024-D-1613.

Questions?

Contact Point
Steven Fleischer
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-110
Rockville, MD 20855
steven.fleischer@fda.hhs.gov
240-402-0809
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