Animal Model Qualification: Frequently Asked Questions (FAQs)

Who evaluates animal model data and makes a determination for animal model qualification?

The initial data evaluation and qualification recommendation is made by the Qualification Review Team (QRT).  This is a multidisciplinary team composed of primary reviewers drawn from offices within CDER and CBER (and others in FDA as appropriate). The team will have at least one member from each of the disciplines necessary to ensure adequate breadth of subject matter expertise for the animal model to be qualified.

What are the benefits of a qualified animal model?

The benefits of a qualified animal model are multiple. For example, the sponsor of an investigational drug can utilize the qualified animal model in its development program within its defined context of use and the model will not require another review or confirmation by the FDA. Use of qualified models will provide for economies of time, animals, and resources in a drug development program under the Animal Rule.

How will the information about a qualified animal model be made publicly available? 

After an animal model is qualified, CDER will publish a notice of the qualification decision in the Federal Register. The final animal model qualification will be published as an addendum to the Qualification Process for Drug Development Tools Guidance. Supporting documents will be posted on this website. 

Who do I contact for more information? 

Center for Drug Evaluation and Research (CDER)
Animal Model Qualification Program Team
Email:  AnimalModelQualification@fda.hhs.gov
Phone:  301-796-2210 

Center for Biologics Evaluation and Research (CBER)
Cynthia Kelley
Email: Cynthia.kelley@fda.hhs.gov
Phone: 301-827-0636