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FDA Advances Drug Development Innovation by Establishing ISTAND as Permanent Qualification Program

The U.S. Food and Drug Administration recognizes that innovating drug development is an important way to bring new treatments to patients and consumers expeditiously. For this reason, the FDA is excited to announce that our Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program has transitioned to a permanent drug development tool (DDT) Qualification Program. 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.

In November 2020, the FDA launched ISTAND to provide a pathway to “qualify” novel DDTs that did not fit within the agency’s existing qualification programs. DDTs are methods, materials, or measures that may help with drug development and may include biomarkers like biological molecules that can signal a condition or disease, or clinical outcome assessments (COAs), which include measurements of a patient’s feelings, ability to function, and survival.