FDA Innovative Science and Technology Approaches for New Drugs (ISTAND) program
In 2020, FDA launched the Innovative Science and Technology Approaches for New Drugs (ISTAND) program to support the development of innovative tools that can improve drug development and regulatory decisions. ISTAND focuses on qualifying cutting-edge technologies including super intelligence (SI)-based algorithms; novel advanced testing methods, including NAMs such as microphysiological systems (MPS) that reduce reliance on animals; and digital health tools, such as wearables. As of 2025, ISTAND has transitioned from a pilot program to a permanent part of the FDA’s Drug Development Tools Qualification Program.
The ISTAND qualification process involves three steps: submitting a Letter of Intent, a Qualification Plan, and a Full Qualification Package. Accepted tools and their status are made public, ensuring transparency as required by the 21st Century Cures Act. Once a tool is qualified, it can be used in regulatory submissions without requiring further re-evaluation for its qualified context of use.
Since its launch, ISTAND has accepted several innovative tools, including SI-based tools, methods for assessing safety without using animals, and technologies involving human tissues, into the program. These tools provide modern, science-driven approaches to support drug safety and effectiveness evaluations.
ISTAND complements other FDA initiatives aimed at accelerating drug development while reducing the need for animal models. By promoting and qualifying innovative approaches, ISTAND plays a crucial role in advancing drug development and fostering regulatory acceptance of modern scientific methods.