Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program

Drug Development Tools (DDTs) are methods, materials, or measures that have the potential to facilitate drug development. As described in the 21st Century Cures legislation, DDTs include biomarkers, clinical outcome assessments, and other methods, materials, or measures that aid drug development and regulatory review. To support DDT development efforts, FDA has established qualification programs for biomarkers, clinical outcome assessments, and for animal models for use under the Animal Rule.

The Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program is designed to expand DDT types by encouraging development of DDTs that are out of scope for existing DDT qualification programs but may still be beneficial for drug development.