FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Seeks Comments on Surrogate Endpoints

Nov. 7, 2018
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The FDA is seeking public comments on an updated table for surrogate endpoints for clinical trials.

The initial list was published last July as part of the 21st Century Cures Act. It already lists surrogate endpoints for diseases from cancer to osteoporosis. The idea is to help speed drug development by giving sponsors a reference guide to consider when setting up trials.

The Cures Act requires the surrogate endpoints list to be updated every six months. The agency says surrogate endpoints will only be considered on a “case-by-case basis.”

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