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FDA Releases Draft Guidance on Human User Safety in New Animal Drug Applications

Update: On June 20, 2024, the FDA issued final Guidance for Industry #278, Human User Safety in New and Abbreviated New Animal Drug Applications. The FDA received one comment submission on the draft guidance, and the comments in that submission were considered as the guidance was finalized. The final guidance was revised to clarify recommendations regarding the use of non-animal based or other alternative methods to demonstrate user safety, use of labeling language to address risks to the human user, and elements of drug handling prior to administration. Other editorial changes were also made to improve clarity. The guidance announced in this notice finalizes the draft guidance dated April 2023.

April 4, 2023

Today the U.S. Food and Drug Administration (FDA) issued draft Guidance for Industry #278, Human User Safety in New and Abbreviated New Animal Drug Applications, to clarify the current approaches and the FDA’s recommendations for Human User Safety (HUS) assessment and submission of HUS information to support the overall safety of proposed new animal drugs prior to approval. 

The draft guidance is intended for sponsors interested in pursuing the approval, or conditional approval, of new animal drugs (including new generic animal drugs) and is also intended for veterinary health professionals and the general public interested in understanding the general principles of HUS assessment for new animal drugs. This guidance is the first document published by the FDA’s Center for Veterinary Medicine (CVM) that is entirely dedicated to the topic of HUS in New and Abbreviated New Animal Drug Applications. This guidance is part of CVM’s ongoing practice to provide transparency and relevant guidance to its stakeholders related to the new animal drug application process.

Human User Safety is an integral component of the overall safety evaluation of proposed new animal drugs. The guidance issued today addresses general principles of HUS assessment for new animal drugs, sources of data, mitigation strategies for proposed new animal drugs, potential recommendations to address HUS concerns, and how HUS information should be submitted to the FDA for pre-approval review. Prior to approval of a new animal drug, drug sponsors should submit information to allow CVM to understand the drug’s unique HUS profile and associated risks. 

CVM recommends drug sponsors consider and discuss the components and methodology of HUS assessment described in this guidance early during the development of their drug and that sponsors have additional discussions as new information pertaining to HUS becomes available during product development. These discussions may be especially important when considering HUS for novel classes or dosage forms of new animal drugs, previously unapproved uses or use conditions of an approved animal drug (e.g., novel routes of administration or target animal species), the impact of formulation or dosage form changes for generic new animal drugs, and during development of applicable drug labeling. In all cases, sponsors are encouraged to contact CVM to discuss the types of information that are recommended to support the HUS assessment of an animal drug or to discuss other questions related to this assessment.

Although GFI #278 focuses solely on pre-approval activities, evaluation of HUS is an ongoing process that continues throughout the development and lifecycle of a new animal drug as new information becomes available. While not a focus of GFI #287, the FDA monitors the safety of approved drugs through adverse drug event reports received from the public or veterinarians and through mandatory reports from pharmaceutical companies. Drug sponsors must provide these reports bi-annually for the first two years following product approval and annually thereafter. Drug sponsors are also required to submit any new studies that have not been previously submitted to the agency. 

The FDA is accepting public comments on the draft guidance for 60 days from the date of publication in the Federal Register. The public should submit either electronic or written comments on the draft guidance by June 5, 2023, to ensure that the Agency considers your comments on this draft guidance before it begins work on the final version of the guidance. 

Comments can be submitted electronically via the Federal eRulemaking Portal, or in writing to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. All submissions received must include the Docket No. FDA-2023-D-0592 for “Human User Safety in New and Abbreviated New Animal Drug Applications.”

For more information:

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

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