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

Issue Date: June 21, 2024
Issued by: Center for Veterinary Medicine
Topic(s): Premarket, Animal Drugs, Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), Labeling, Safety – Issues, Errors, and Problems, Pharmacology/Toxicology
Status: Final

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

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.

Download the Guidance Document

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