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  1. Development & Approval Process (Drugs)

Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA

Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA

These tables provide the current number of Drug Development Tool (DDT) projects grouped overall, by Program, and DDT stage. Please note, the stage of the DDT is determined by the last submission accepted by the FDA (Letter of Intent, Qualification Plan, Full Qualification Package). For example, if a requestor’s Letter of Intent (LOI) was accepted into the qualification program, the DDT is in the LOI stage as the requestor works toward the Qualification Plan. The numbers in the tables are not meant to be summative.

The tables are updated and reported on a biannual (twice a year) basis. Refer to DDT Contacts and Submitting Procedures for contact information for each DDT Program.

All DDT Qualification Programs

 Number of Projects in Development

 80

 Number of Reviewable Letters of Intent (LOIs)* 

 17

 Number of Reviewable Qualification Plans (QPs)*

 2

 Number of Reviewable Full Qualification Packages (FQPs)*

 3

 Number of Newly Qualified DDTs Since Last Reporting

 2

 *Received between July 1, 2018 and December 31, 2018.

Biomarker Qualification Program

 

 Number of Projects in Development

 37

 Number of Reviewable Letters of Intent (LOIs)* 

 8

 Number of Reviewable Qualification Plans (QPs)*

 2

 Number of Reviewable Full Qualification Packages (FQPs)*

 2

 Number of Newly Qualified DDTs Since Last Reporting

 2

 *Received between July 1, 2018 and December 31, 2018.

Clinical Outcome Assessments Qualification Program

 

 Number of Projects in Development

 43

 Number of Reviewable Letters of Intent (LOIs)* 

 9

 Number of Reviewable Qualification Plans (QPs)*

 0

 Number of Reviewable Full Qualification Packages (FQPs)*

 1

 Number of Newly Qualified DDTs Since Last Reporting

 0

*Received between July 1, 2018 and December 31, 2018.