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# Guide on Animal Drug Human Safety Assessments
- URL: https://www.fdaweb.com/guide-on-animal-drug-human-safety-assessments/
- Published: 2023-04-04T12:00:00.000Z
- Updated: 2026-09-14T18:23:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154127

FDA has released a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cvm-gfi-278-human-user-safety-new-and-abbreviated-new-animal-drug-applications?ref=fdaweb.com) entitled “Human User Safety in New and Abbreviated New Animal Drug Applications.” The agency says that the FD&C Act does not provide specific guidance on data requirements or assessment methods to identify the risks or risk mitigation measures for human users of new animal drugs. Therefore, the guidance is intended to clarify current approaches and recommendations for human user safety (HUS) assessments and subsequent submissions of such information to support the overall safety of proposed new animal drugs prior to approval.

CVM evaluates HUS assessments under the regulatory framework of the Target Animal Safety technical section for new animal drugs, the guidance says. “HUS covers human exposures to a new animal drug or its metabolites resulting from expected or anticipated conditions of use or from foreseeable accidents associated with the use of the new animal drug,” it says. “CVM does not routinely expect HUS assessment for new animal drugs to address conditions of exposure that may result from deliberate extralabel use, misuse, or abuse of a drug. However, for new animal drugs that contain active substances categorized as ‘controlled substances,’ or that may otherwise be deliberately misused, it may be warranted for drug sponsors to include additional considerations or mitigation strategies (e.g., special packaging conditions) to limit or prevent access or intentional misuse of the drug.”