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Opportunities and Risks of a Single-Trial Default for FDA Drug Approval

JAMA Health Forum 10.1001/jamahealthforum.2026.2756

September 04, 2026 at 11:00 AM EDT

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This Viewpoint describes potential concerns and opportunities with a single-trial default for US Food and Drug Administration (FDA) drug approval.

Corresponding Author: Holly Fernandez Lynch, JD, MBE, Perelman School of Medicine, University of Pennsylvania, 3600 Civic Center Blvd, Philadelphia, PA 19104 (lynchhf@pennmedicine.upenn.edu).

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