Summary Metrics of Drug Development Tool Qualification Projects Submitted to FDA
Update | February 5, 2024
The Drug Development Tool (DDT) Qualification Programs have updated the program metrics to give the public and industry partners more clarity and transparency around our activities. In accordance with the 21st Century Cures Act, we will report on the number of submissions accepted within each reporting period and report on the total number of qualified measures to date.
These tables provide the current number of Drug Development Tool (DDT) projects grouped overall, by Program, and DDT stage of review. 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 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. To locate projects that have been qualified and projects under development, please visit the CDER and CBER Drug Development Tool Qualification Project Search Database.
All DDT Qualification Programs
| Total Number of Projects in Development |
123 |
|---|---|
| Number of Letters of Intent (LOIs) Accepted* |
108 |
| Number of Qualification Plans (QPs) Accepted* |
14 |
| Number of Newly Qualified DDTs in past 12 months |
0 |
| Total Number of Qualified DDTs To Date |
17 |
*As of December 31, 2023
Animal Model Qualification Program
| Total Number of Projects in Development |
6 |
|---|---|
| Number of Letters of Intent (LOIs) Accepted* |
5 |
| Number of Qualification Plans (QPs) Accepted* |
0 |
| Number of Newly Qualified DDTs in past 12 months |
0 |
| Total Number of Qualified DDTs To Date |
1 |
*As of December 31, 2023
Biomarker Qualification Program
| Total Number of Projects in Development |
46 |
|---|---|
| Number of Letters of Intent (LOIs) Accepted* |
41 |
| Number of Qualification Plans (QPs) Accepted* |
5 |
| Number of Newly Qualified DDTs in past 12 months |
0 |
| Total Number of Qualified DDTs To Date |
9 |
*As of December 31, 2023
Clinical Outcome Assessment Qualification Program
| Total Number of Projects in Development |
68 |
|---|---|
| Number of Letters of Intent (LOIs) Accepted* |
59 |
| Number of Qualification Plans (QPs) Accepted* |
9 |
| Number of Newly Qualified DDTs in past 12 months |
0 |
| Total Number of Qualified DDTs To Date |
7 |
*As of December 31, 2023
Innovative Science and Technology Approaches for New Drugs (ISTAND)1
| Total Number of Projects in Development |
3 |
|---|---|
| Number of Letters of Intent (LOIs) Accepted* |
3 |
| Number of Qualification Plans (QPs) Accepted* |
0 |
| Number of Newly Qualified DDTs in past 12 months |
0 |
| Total Number of Qualified DDTs To Date |
0 |
*As of December 31, 2023
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.