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# FDA Makes ISTAND Pilot Permanent
- URL: https://www.fdaweb.com/fda-makes-istand-pilot-permanent/
- Published: 2025-07-31T12:00:00.000Z
- Updated: 2026-09-14T15:17:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159603

FDA says the Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program has transitioned to a permanent drug development tool (DDT) qualification program. An *FDA Voices* post, written by CDER Office of Translational Sciences director **ShaAvhrée Buckman-Garner** and Office of New Drugs acting director **Mary Thanh Hai**, says ISTAND “will continue to support innovative, science-driven approaches that improve drug development and regulatory decision-making, ultimately helping to make therapies available to address patients’ unmet needs.”

The post says FDA launched ISTAND in 11/2020 to provide a pathway to qualify novel DDTs that did not fit within its existing qualification programs.

The pilot helped facilitate the integration of advanced tools, such as organ-on-a-chip models, artificial intelligence (AI)-enabled tools, digital health technologies, and complex *in vitro* models into regulatory science, Buckman-Garner and Hai write.

Since 2020, the pilot has accepted eight submissions — three AI-based tools, two tools that assess preclinical safety without using animals, two novel methods involving tissues, and one novel statistical approach, the post says.