Drug Development Tool (DDT) Qualification Projects at CDER, FDA

This Table provides the current[1] number of active CDER Drug Development Tool (DDT) Qualification projects overall and by Program. Numbers are also provided by stage. Refer to DDT Contacts and Submitting Procedures for contact information for each DDT Program.

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 All Drug Development Tool (DDT) Qualification Programs

DDT - Animal Model Qualification Program

DDT - Biomarker Qualification Program

DDT - Clinical Outcome Assessments

Total Number of Active Projects73815[2]50
Number in Initiation Stage 233416
 Number in Consultation and Advice Stage405728
Number in Review Stage 8044
Number Qualified

[1] Numbers are updated on a quarterly basis.

[2] Active Projects are defined by Biomarker Qualification Programs as last interaction with requestor within one calendar year.

Page Last Updated: 08/15/2017
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