FDA Updates DDT Metrics: 160 Projects Active As Of July 2026

With 160 Drug Development Tool projects now in active development and only 22 qualified to date, FDA's September 2026 metrics update for its DDT Qualification Programs and ISTAND Program draws a sharp line between pipeline volume and qualification throughput, a gap regulatory affairs leads should factor into submission planning for 2027.

The figures, current as of July 31, 2026, are reported biannually under the 21st Century Cures Act, which mandates FDA disclose the number of submissions accepted per reporting period and the cumulative count of qualified measures. Stage classification is determined by the last submission FDA accepted, Letter of Intent, Qualification Plan, or Full Qualification Package, meaning a project's recorded stage reflects where the requestor is actively working, not where it has been approved.

Across all programs, 141 Letters of Intent have been accepted against only 19 Qualification Plans, indicating that the majority of active projects remain at the earliest formal stage of review. Five DDTs were newly qualified in the past 12 months, bringing the all-program total to 22. The Biomarker Qualification Program carries the heaviest qualified load, 11 qualified DDTs, 3 newly qualified in the past year, while the Clinical Outcome Assessment program added 2, reaching 10 total. The Animal Model Qualification Program has produced one qualified DDT across five projects in development, with no new qualifications in the past 12 months.

The ISTAND Program, which covers innovative science and technology approaches for new drugs, shows 27 projects in development and 24 LOIs accepted, but zero qualified DDTs to date. ISTAND submissions reviewed under the DDT qualification process are counted in both the ISTAND table and the all-programs aggregate; those not reviewed under that process appear only in the ISTAND table. Regulatory teams working with novel methodologies under ISTAND should account for this dual-counting structure when benchmarking program progress against overall DDT figures.

For teams preparing qualification submissions, FDA directs requestors to the DDT Contacts and Submitting Procedures page for program-specific contacts, and to the CDER and CBER DDT Qualification Project Search Database to locate both qualified projects and those currently under development.

The next biannual metrics update will serve as a measurable checkpoint on whether the five newly qualified DDTs in the past 12 months represent a sustained qualification rate or a one-period variance against the broader 160-project pipeline.

Source: FDA via What's New: Drugs RSS Feed, September 8, 2026.