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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Download the Draft Guidance Document Read the Federal Register Notice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Not for implementation.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.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2024-D-1613

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.

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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