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# Pilot on Innovative Drug Development Tools
- URL: https://www.fdaweb.com/pilot-on-innovative-drug-development-tools/
- Published: 2020-12-07T12:00:00.000Z
- Updated: 2026-09-14T16:39:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148242

FDA is detailing the launch of a new pilot program to provide a pathway for novel drug development tools (DDTs) to be used in regulatory applications for new medical products. The program, [*Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program*](https://www.fda.gov/drugs/drug-development-tool-ddt-qualification-programs/innovative-science-and-technology-approaches-new-drugs-istand-pilot-program?ref=fdaweb.com)*,* is intended to streamline and potentially speed up new drug and biologic development. “For instance, the scientific community is making great strides with artificial intelligence and microphysiological models — which are miniature models of human organs or connected systems,” an [agency post](https://www.fda.gov/drugs/news-events-human-drugs/cder-focuses-novel-drug-development-tools-help-speed-creation-new-therapies?ref=fdaweb.com) says. “These both could be types of DDTs that lead to rapid advances in developing new drugs,” it says.

The plan is to evaluate novel DDTs similar to how FDA currently evaluates biomarkers and *clinical outcome assessments*, but with more feedback from the agency when needed. Some examples FDA would consider under the pilot include:

- Data collection or analysis methods that differ from current standard approaches
- Tissue chips, which are miniature models of human organs, for safety assessments
- Certain digital health technologies, including artificial intelligence or wearable sensors, used during clinical trials