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Updated: Jan 8, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
Surrogate Endpoints in Regulatory Decision-Making
Linda J B Jeng1, Jeffrey Siegel2
1Division of Biomedical Informatics, Research, and Biomarker Development, Office of Drug Evaluation Sciences, Office of New Drugs, Center for Drug Evaluation and Research, FDA, Silver Spring, Maryland, USA.
None:
To support approval, FDA requires substantial evidence of effectiveness that demonstrates a drug improves meaningful clinical outcomes as measured by how a patient feels, functions, or survives. Effectiveness is measured directly (e.g., by patient-reported outcome or other clinical outcome assessment) or indirectly (i.e., by use of a surrogate endpoint (SE) that predicts how a patient will feel, function, or survive). Use of biomarkers as SEs can hasten drug development for patients with unmet medical needs.
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