I was recently discussing the FDA’s Drug Development Tool (DDT) qualification program with a colleague. They questioned the utility of the pathway and I’ve heard similar sentiment from others over the past year or two. For people not deeply familiar with the DDT pathway here’s some additional context:
The pathway was created in 2016 as part of the 21st Century Cures Act and outlined 3 streams: 1) biomarkers, 2) clinical outcome assessments and 3) animal models. It was intended to help spur the development of tools outside of the IND/NDA/BLA pathway. As of January 1st, 2026 only 8 COAs have been fully qualified - this is less than one per year since the program started.
Yang and colleagues (2025) did a deep dive on the efficacy of the program. At the time they did their research only 7 were fully qualified - none since 2020 and all of the ones that were qualified had been submitted right before the program was created. Additionally, all the qualified COAs were qualified as measures for exploratory use. Finally, the average time for qualification was 6 years!
Given that most COAs used in trials never went through the DDT qualification process, this begs the question: is there value going through the pathway? Is it easier to just develop tools through the existing IND/NDA/BLA pathways?