Tag: Dr. Scott Gottlieb

Dr. Scott Gottlieb

Regulatory/FDA

FDA After Gottlieb: Will Sharpless Stay the Course?

FDA After Gottlieb: Will Sharpless Stay the Course?

June 3, 2019 – In the wake of Dr. Scott Gottlieb’s recent departure from the FDA and the appointment of Acting FDA Commissioner Dr. Ned Sharpless, industry can expect Sharpless to continue many of the initiatives and action plans established by Gottlieb, who was one of the most activist FDA commissioners in FDA history, according […]

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Regulatory/FDA

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

New FDA Guidance on Clinical Trial Design—and an Admonition from Commissioner Gottlieb

March 18, 2019 — With mere days left before his departure as FDA Commissioner, Dr. Scott Gottlieb is trying to focus attention on one of the lesser-known of his major initiatives – improving the design of clinical trials in drug development. In a statement released along with the publication of a new guidance, Gottlieb highlighted […]

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Regulatory/FDA

Sharpless to Succeed Gottlieb at FDA on Acting Basis

Sharpless to Succeed Gottlieb at FDA on Acting Basis

March 13, 2019 — The Trump administration wasted little time in appointing an acting FDA Commissioner: Dr. Norman (Ned) Sharpless – currently director of the National Cancer Institute – has been tapped to succeed Dr. Scott Gottlieb (who resigned March 5) on a temporary basis. Sharpless is a physician and former director of the Lineberger […]

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