The process for DDT qualification provides a framework for interactions between CDER 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.
 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