DDT Qualification Process

The process for DDT qualification provides a framework for interactions between CDER[1] and DDT requestors 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 requestors to advance DDT development. 

New! Change in Process for Qualification of Drug Development Tools

The process for qualification of drug development tools is changing under new FD&C Act Section 507. FDA is posting information about these updates to the DDT submission processes.

Check for details, documents and information consistent with new section 507(c).

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



Page Last Updated: 08/15/2017
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