Tag: Acting FDA Commissioner

Acting FDA Commissioner

Washington Focus

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Pressure Mounting for FDA Commissioner Among Reports that Califf Will Be Biden’s Choice

Oct. 21, 2021—Nine months into President Joe Biden’s administration, he has still not nominated a candidate to take the helm at the Food and Drug Administration (FDA). Amid the COVID-19 pandemic and other pressing healthcare issues, the pressure is rising for a permanent FDA commissioner, but many of the frequently-named frontrunners for the position appear […]

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Regulatory/FDA

FDA Plans Expedited Approval Path for Modified COVID-19 Vaccines

FDA Plans Expedited Approval Path for Modified COVID-19 Vaccines

Feb. 8, 2021 – With growing concern about the spread of new COVID-19 variants, companies developing vaccine modifications will not have to “start at square one,” according to Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, M.D.. Because of early indications that the initial vaccines may have lower effectiveness against one or more of […]

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Regulatory/FDA

Woodcock to Take Helm While Biden Considers FDA Commissioner Choice

Woodcock to Take Helm While Biden Considers FDA Commissioner Choice

Jan. 18, 2021 – Under the Biden administration, longtime Center for Drug Evaluation and Research (CDER) director and FDA veteran Janet Woodcock, M.D., has been tapped to serve as the acting commissioner of the Food and Drug Administration (FDA) after current FDA Commissioner Stephen Hahn, M.D., stepped down on Jan. 20. Media reports suggest that […]

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Regulatory/FDA

Dr. Stephen Hahn Nominated for FDA Commissioner Position

Dr. Stephen Hahn Nominated for FDA Commissioner Position

Nov. 1, 2019 – In a statement issued by the White House, President Donald J. Trump today nominated Stephen Hahn, M.D., to be Commissioner of the Food and Drug Administration (FDA). Hahn is a radiation oncologist, experienced clinical trial investigator, and coauthor of more than 200 papers. He previously served as Chair of Radiation Oncology […]

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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’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

FDA’s Second Half: Org Changes, Updating Trial Design and Promotional Regulation, 2020 Budget

July 1, 2019 – Among the issues on the Food and Drug Administration’s (FDA’s) plate for the remainder of 2019 are implementing organizational changes, securing appropriations funding for 2020, modernizing clinical trial design and regulating promotional messaging, according to Nancy Bradish Myers, president, Catalyst Healthcare Consulting, who spoke at the recent Coalition for Healthcare Communication […]

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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

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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