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Amanda J. Koong

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Review Open access Aug 2026

Changes in evidence used for FDA Novel Drug Approvals: 2016-2024

Background The 21st Century Cures Act (2017) was enacted during a period of evolving FDA flexibility in evidentiary standards for drug approval. To examine trends before and after implementation, we independently reviewed all novel drugs approved between 2016 and 2024. Methods We constructed a database of all novel FDA...

Aditya Narayan, Veronica L. Irvin, Amanda J. Koong et al. · 0 citations

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