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In this section: Drug Development Tool (DDT) Qualification Programs

Animal Model Qualification Program | AMQP

To locate a project, go to CDER & CBER’s DDT Qualification Project Search database

A product-independent, resource-conserving approach to advance the development of animal models for use in Animal Rule applications

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Overview of the Animal Model Qualification Program

Learn about the program and how it can help advance the development of critically needed animal models for products developed under the Animal Rule

Animal Rule Information

Learn about the regulations for the approval of new drugs and biological products when human efficacy studies are not ethical or feasible

The Animal Model Qualification Process

Learn about the process and access submission content outlines

Submit to the Animal Model Qualification Program

Get contact and submission information for the Animal Model Qualification Program

Resources for the Animal Model Qualification Program

Find useful resources, including guidances and websites

Frequently Asked Questions

About the Animal Model Qualification Program

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