Diffusing authority to make drug approval decisions at the US Food and Drug Administration

Diffusing authority to make drug approval decisions at the US Food and Drug Administration

Nature Medicine, Published online: 29 September 2025; doi:10.1038/s41591-025-03948-5

The US Food and Drug Administration (FDA) is at a crossroads. There is an urgent need to strengthen the integrity of drug approvals and rejections by diffusing the decision-making authority of individual officials and improving transparency when disagreements arise.

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Diffusing authority to make drug approval decisions at the US Food and Drug Administration

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