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U.S. Department of Health and Human Services


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DDT Qualification Process


The process for DDT qualification provides a framework for interactions between CDER[1] and DDT submitters to guide the collection of data to support a DDT’s prospectively specified context of use (COU).  The qualification process consists of three stages:  (1) an initiation stage, (2) a consultation and advice stage, and (3) a review stage for the qualification determination.  The appropriate review offices will participate in the entire qualification process for the DDT. The goal of the process is to reach a determination about the adequacy of the submitted data to support DDT qualification within a COU. CDER intends to interact actively with DDT submitters to advance DDT development.  

The DDT qualification process is illustrated in the process flow diagram below.

[1] The Animal Model Qualification Program is being developed by CDER in collaboration with FDA’s Center for Biologics Evaluation and Research (CBER).




DDT Qualification Process

DDT Qualification Process