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CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications April 2023


Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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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can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.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-2023-D-0592

Docket Number:
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Human User Safety (HUS) is an integral component of the overall safety evaluation of proposed new animal drugs. The FD&C Act does not provide specific guidance on data requirements or assessment methods to identify the risks or the risk mitigation measures for human users of new animal drugs. This guidance clarifies the current approaches and recommendations for HUS assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval.


Contact Point
Karen Sussman
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-114
Rockville, MD 20855
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