GUIDANCE DOCUMENT
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Not for implementation.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This guidance is being distributed for comment purposes only.
- Docket Number:
- FDA-2023-D-0592
- Issued by:
-
Guidance Issuing OfficeCenter 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.
Questions?
- Karen Sussman
- Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Place, HFV-114
Rockville, MD 20855
- karen.sussman@fda.hhs.gov
- 240-402-0876