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 first row of each table is 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 |
163 |
|
Number of Reviewable Letters of Intent (LOIs)* |
17 |
|
Number of Reviewable Qualification Plans (QPs)* |
6 |
|
Number of Reviewable Full Qualification Packages (FQPs)* |
0 |
|
Number of Newly Qualified DDTs Since Last Reporting |
1 |
*Received between January 1, 2021 and December 31, 2021
Animal Model Qualification Program
|
Number of Projects in Development |
5 |
|
Number of Reviewable Letters of Intent (LOIs)* |
4 |
|
Number of Reviewable Qualification Plans (QPs)* |
0 |
|
Number of Reviewable Full Qualification Packages (FQPs)* |
0 |
|
Number of Newly Qualified DDTs Since Last Reporting |
1 |
*Received between January 1, 2021 and December 31, 2021
Biomarker Qualification Program
|
Number of Projects in Development |
80 |
|
Number of Reviewable Letters of Intent (LOIs)* |
7 |
|
Number of Reviewable Qualification Plans (QPs)* |
5 |
|
Number of Reviewable Full Qualification Packages (FQPs)* |
0 |
|
Number of Newly Qualified DDTs Since Last Reporting |
0 |
*Received between January 1, 2021 and December 31, 2021
Clinical Outcome Assessments Qualification Program
|
Number of Projects in Development |
64 |
|
Number of Reviewable Letters of Intent (LOIs)* |
6 |
|
Number of Reviewable Qualification Plans (QPs)* |
1 |
|
Number of Reviewable Full Qualification Packages (FQPs)* |
0 |
|
Number of Newly Qualified DDTs Since Last Reporting |
0 |
*Received between January 1, 2021 and December 31, 2021
Innovative Science and Technology Approaches for New Drugs (ISTAND)1
| Total Number of Submissions Received* | 14 |
*Received between January 1, 2021 and December 31, 2021
1 ISTAND submissions that are reviewed under the DDT qualification process are included under “All DDT Qualification Programs” above as well as in the ISTAND table. ISTAND submissions that are not reviewed under the DDT qualification process are only included in the ISTAND table. For more information on ISTAND, please visit the ISTAND webpage.