Tag: FDA Commissioner

FDA Commissioner

6/4/21 Webinar: FDA Update: New leadership, initiatives and challenges


Friday, June 4, 2021, 12-1 pm ET What happens at the FDA is central to all health marketing and communications, controlling the flow of new drug approvals and regulating what manufacturers may say about their products. The agency has been through unprecedented challenges over the past two years. Now, with a new president and new (more…)

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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

Myers: What the FDA Might Look Like Under Biden

Myers: What the FDA Might Look Like Under Biden

Dec. 21, 2020 – As President-elect Joe Biden takes office in January 2021, understanding what could change and what could remain the same at the FDA is important, according to Nancy Bradish Myers, president and CEO of Catalyst Healthcare Consulting Inc. Myers, who has held key positions at the FDA and in industry, spoke at […]

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Washington Focus

Rawson Previews Biden COVID-19 Approach and Vaccine Roll-out

Rawson Previews Biden COVID-19 Approach and Vaccine Roll-out

Nov. 30, 2020 – Job one for President-elect Joe Biden is the response to the COVID-19 pandemic, which will represent a “marked difference in energy and tone” than that offered by the current administration and likely will include a new FDA Commissioner as well as the roll-out of COVID-19 vaccines, according to Kate Rawson, senior […]

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Regulatory/FDA

Hahn: Lessons Learned in Pandemic May Lead to Permanent FDA Changes

Hahn: Lessons Learned in Pandemic May Lead to Permanent FDA Changes

June 9, 2020 – Speaking at a June 1 presentation to the Alliance for a Stronger FDA, FDA Commissioner Dr. Stephen Hahn said that despite criticisms of its performance during the COVID-19 pandemic, FDA’s “decisions [will] always be rooted in science,” and that lessons learned during the pandemic “will lead to permanent improvements at the […]

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Washington Focus

Senate Confirms Hahn to Be Next FDA Commissioner

Senate Confirms Hahn to Be Next FDA Commissioner

Dec. 13, 2019 – In a vote of 72-18 the Senate yesterday confirmed Dr. Stephen Hahn to take the helm of the Food and Drug Administration even though it had been predicted that the vote to confirm Hahn as FDA Commissioner might be pushed to 2020 in light of competing priorities like the budget and […]

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Washington Focus

Hahn Confirmation Hearing Reveals Little about FDA Commissioner Nominee

Hahn Confirmation Hearing Reveals Little about FDA Commissioner Nominee

Nov. 20, 2019 – In today’s Senate confirmation hearing for Dr. Stephen Hahn, President Donald Trump’s nominee for the Commissioner of Food and Drugs position, Senate Health, Education, Labor, and Pensions (HELP) Committee members questioned Hahn on such topics as opioids, generic drugs, updating the over-the-counter drug monograph, regulating cannabis-related products, and combatting shortages of […]

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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 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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