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Real-World Evidence in Drug Approvals at the European Medicines Agency

JAMA Network Open 10.1001/jamanetworkopen.2025.42041

November 06, 2025 at 11:00 AM EST

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This cross-sectional study assesses how the European Medicines Agency incorporated routinely collected clinical data into its approval processes from 2020 to 2023.

Corresponding Author: Nils Krüger, MD, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital/Harvard Medical School, 1620 Tremont St, Ste 3030, Boston, MA 02120 (nkruger1@bwh.harvard.edu).

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