Tag: FDA Commissioner

FDA Commissioner

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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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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Regulatory/FDA

Gottlieb Departure from FDA Surprises Industry

Gottlieb Departure from FDA Surprises Industry

March 6, 2019 — FDA Commissioner Scott Gottlieb, M.D., recently stated that he was not leaving the FDA, so news of his departure at the end of the month sent shock waves through FDA-regulated industry yesterday. Citing a need to spend more time with his family, Gottlieb tweeted that he is “immensely grateful for the […]

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Regulatory/FDA

Gottlieb: FDA Has Vital Role to Play in Addressing Opioid Crisis

Gottlieb: FDA Has Vital Role to Play in Addressing Opioid Crisis

Oct. 30, 2017 – FDA Commissioner Scott Gottlieb, M.D., is taking a strong leadership position in light of the nation’s opioid crisis, making a statement, in response to President Donald J. Trump’s declaration of the crisis as a public health emergency, that the FDA “has a vital role to play” on this issue, and telling […]

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Gottlieb Vote Headed to Full Senate

May 1, 2017 – Having cleared the Senate Committee on Health, Education, Labor and Pensions (HELP) with a 14-9 vote on April 27, Dr. Scott Gottlieb’s nomination to be the next FDA commissioner is now headed for a full Senate vote. So far, Gottlieb’s nomination has moved quickly and smoothly through the nomination process. “Gottlieb […]

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Regulatory/FDA

Gottlieb Is “Known” Entity to Pharma Industry

Gottlieb Is “Known” Entity to Pharma Industry

March 20, 2017 – Although medical marketers are very familiar with Scott Gottlieb, President Donald Trump’s choice for the top job at the FDA and a former FDA deputy commissioner for medical and scientific affairs, they can only make educated guesses about how he will run the agency of 14,000 people and what his positions […]

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Regulatory/FDA

Trump Needs to Take a Closer Look at FDA Performance

Trump Needs to Take a Closer Look at FDA Performance

March 8, 2017 – In an open letter to President Donald Trump, Pharmalot’s Ed Silverman asks that before Trump criticizes and plans any reform of the Food and Drug Administration (FDA), he should take a hard look at how the agency has performed in recent years. “During the past decade, the FDA has increasingly used […]

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CHC News

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

Industry Peacekeeping with President Trump Holds Promise But Portends Danger

By John Kamp, Executive Director, Coalition for Healthcare Communication [Editor’s Note: This “The Final Word” column appeared in the February 2017 edition of MedAdNews and is reprinted with permission.] As a public official preparing for international negotiations, I was taught by the U.S. State Department to always know exactly what you want and what you’re […]

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