Tag: Ned Sharpless

Ned Sharpless

Regulatory/FDA

Gottlieb: Lack of Permanent FDA Commissioner Has an Impact

Gottlieb: Lack of Permanent FDA Commissioner Has an Impact

Oct. 14, 2019 — “I’d be lying if I said it didn’t have an impact.” That’s how former FDA Commissioner Scott Gottlieb responded when asked last week at the BioPharma Congress in Washington, D.C., whether it matters if the FDA is led by an acting or a permanent Commissioner, even as reports swirl in Washington that […]

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Regulatory/FDA

FDA Leaders Highlight Issues, Opportunities of Real-world Data Post-marketing

FDA Leaders Highlight Issues, Opportunities of Real-world Data Post-marketing

May 6, 2019 — “It doesn’t just take a village, it takes an ecosystem,” Jeffrey Shuren, M.D., J.D., director of the Center for Devices and Radiological Health (CDRH), told the annual meeting of the Reagan-Udall Foundation for the FDA in Washington on May 2, highlighting the challenge of drawing upon a sufficiently broad range of […]

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