> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Drug Development Tool Qualification Stats
- URL: https://www.fdaweb.com/fda-drug-development-tool-qualification-stats/
- Published: 2020-07-23T12:00:00.000Z
- Updated: 2026-09-14T16:22:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147268

FDA has published tables summarizing the current number of drug development tool qualification projects, grouped overall by program and development tool stage. The [document](https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/summary-metrics-drug-development-tool-qualification-projects-submitted-fda?ref=fdaweb.com) says the development tool stage is determined by the last submission accepted by the agency. The tables are updated and reported twice a year.

The overall summary shows 123 projects in development, 22 reviewable letters of intent, three reviewable qualification plans, no reviewable full qualification packages, and one newly-qualified drug development tool since last reporting.

The overall statistics are broken down for animal models, biomarkers, and clinical outcome assessments.