Background
This webapp has an overview on Regulatory science and Drug development tools (DDTs), in different stages of their development and based on information made publicly available by the EMA and FDA. Developers of such tools include academia, public-private consortia and for-profit entities. Public information on the stage of research and development of these tools and methodologies serves the broader community of developers and researchers to use the tools for their activities and may lead to investigate expanding their use. The tools in this webapp include:
- EMA Letters of support for Novel methodologies
- EMA Qualification opinions for Novel methodologies
- FDA CDER & CBER Drug Development Tool Qualification
- FDA CDRH Regulatory Science Tools Catalog
- FDA CBER CDER Surrogate endpoints
- FDA CBER CDER Fit for purpose
- FDA Qualified Medical Device Development Tools (MDDTs)
Webapp
Changes
- 2025-10-26 mechanism to update at least once weekly
- 2025-10-18 added FDA’s Qualified Medical Device Development Tools (MDDTs)
- 2025-06-22 added FDA’s CDRH peer-reviewed regulatory science tools catalogue
- 2025-04-21 implement more robust approach
- 2025-03-16 added explanations and latest FDA status
- 2025-01-13 updated to changes on FDA and EMA websites
- 2024-05-05 updated to changed FDA website
- 2023-12-07 updated to new EMA website
- 2023-11-18 add proposers for EMA, complete for FDA
- 2023-09-23 list all DDT document types
- 2023-08-20 added FDA’s Fit for purpose outputs
- 2023-05-13 initial release, covering five different sourceTypes