External Collaboration At US FDA Is More Difficult Than At NIH, Sharpless Says
Acting US FDA commissioner Norman Sharpless outlines some key differences between his new position and his former role at the NCI.
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Acting commissioner is entering the usual learning curve for new leaders of the agency. It’s a reminder of how unusual it was to skip that step under his predecessor.
Independence, But Not Isolation: Panel Of FDA Commissioners Reflect On Role Of Dialogue With External Stakeholders
US FDA Commissioner Scott Gottlieb and three former agency heads tout value of deliberation with broader scientific community, but also agency's ability to make regulatory decisions independently.
US drugs with accelerated approval are more likely to experience a postmarket safety event, JAMA study finds; data sharing could be a solution to filling information gaps.