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  • Regulatory NewsRegulatory News

    Trump Nominates Hahn to be FDA Commissioner

    President Donald Trump on Friday nominated Stephen Hahn, chief medical executive of the MD Anderson Cancer Center in Houston, to be the next US Food and Drug Administration (FDA) commissioner. If confirmed by the Senate, a process that could take several months, Hahn will take the reins of FDA from Acting Commissioner Ned Sharpless, who moved over to FDA following a stint as head of the National Cancer Institute (NCI). Sharpless will return to direct NCI, while Brett Gi...
  • Regulatory NewsRegulatory News

    As the Race for a Permanent FDA Commissioner Picks Up, Agency Turnover Continues

    With a decision on a permanent US Food and Drug Administration (FDA) Commissioner slated for the end of October at the latest, the steady stream of FDA employee defections to industry continues. So, who will be nominated as the next commissioner? Some influential health groups and former FDA commissioners (including Scott Gottlieb), according to the Washington Post , are pushing for Acting Commissioner Ned Sharpless to be nominated, while the Wall Street Journal...
  • RAPS' LatestRAPS' Latest

    Video: FDA Commissioner Scott Gottlieb's Keynote Speech at the 2017 Regulatory Convergence

    • 28 September 2017
    • By
    US Food and Drug Administration Commissioner Scott Gottlieb addressed attendees of RAPS’ 2017 Regulatory Convergence on 11 September. He focused his remarks on making the clinical end of drug development more efficient and effective . If you missed it or would like to see his presentation again, the video is embedded below.
  • Regulatory NewsRegulatory News

    Gottlieb Targets Drug Development Costs, Clinical Development Efficiencies

    FDA commissioner Scott Gottlieb on Monday explained to attendees of RAPS’ Regulatory Convergence conference some steps FDA is taking to make the clinical end of drug development more efficient and effective. Opening with a discussion of the ways in which the gap of time between the discovery of the science behind new treatments and the adoption of such treatments has been shrinking, Gottlieb outlined a few of the ways in which the agency is modernizing its approach t...
  • RAPS' LatestRAPS' Latest

    UPDATE: FDA Commissioner Scott Gottlieb to Deliver Keynote at RAPS Regulatory Convergence

    US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, will address the global regulatory community on 11 September, delivering keynote remarks at the 2017 Regulatory Convergence conference at National Harbor on the DC Waterfront. The commissioner's keynote presentation was originally scheduled to take place during the opening plenary session, but is now scheduled as a lunchtime session on Monday, 11 September. The Convergence will take place 9–12 Septem...
  • Regulatory NewsRegulatory News

    Gottlieb to FDA Staff: Immediate Challenge is Opioid Abuse

    Scott Gottlieb, the US Food and Drug Administration’s (FDA) new commissioner, addressed agency staff for the first time late Monday, telling them that "unquestionably, our greatest immediate challenge is the problem of opioid abuse." "This is a public health crisis of staggering human and economic proportion. The epidemic of opioid addiction is not a problem that FDA can solve alone. But we have an important role to play in reducing the rate of new abuse, and in g...
  • Regulatory NewsRegulatory News

    10 Hot-Button Issues FDA’s New Commissioner Will Face

    Like his predecessors, Scott Gottlieb, the newly sworn-in commissioner of the US Food and Drug Administration (FDA), will have a full plate to tackle as he takes the reins of the short-staffed agency. Opioid Epidemic At the forefront of the agenda is what Gottlieb called his "highest immediate priority" in the confirmation hearing: the opioid crisis. While acknowledging that FDA’s past actions may have been too incremental, Gottlieb will now have to deal with ...
  • Regulatory NewsRegulatory News

    Senate Confirms Gottlieb as Next FDA Commissioner

    The Senate on Tuesday afternoon voted along party lines to confirm Dr. Scott Gottlieb as the next US Food and Drug Administration (FDA) commissioner. Gottlieb, who faced limited resistance during his Senate committee hearing for his close financial ties to industry, will fill a position most recently held by Dr. Robert Califf , who served under President Barack Obama until last January. In his confirmation hearing, and unlike several other Trump nominees, Gottli...
  • Regulatory NewsRegulatory News

    Senate Committee Advances Gottlieb Nomination as FDA Commissioner

    The Senate Health, Education, Labor & Pensions committee on Thursday advanced Dr. Scott Gottlieb’s nomination to lead the US Food and Drug Administration (FDA). The 14-9 vote, a day after a delay , was largely along party lines (Democrat Sens. Michael Bennet (D-CO) and Sheldon Whitehouse (D-RI) voted aye) and follows a back and forth on Gottlieb’s experience seen in the hearing to consider his nomination. Prior to the vote, Sen. Lamar Alexander (R-TN) praised ...
  • Regulatory NewsRegulatory News

    Senate HELP Committee Delays Vote on Gottlieb Nomination

    Senate HELP Committee Chairman Lamar Alexander (R-TN) on Wednesday delayed an expected vote on Scott Gottlieb's nomination to head the US Food and Drug Administration (FDA). Alexander said the vote was being delayed to give senators more time to "consider whatever information they want to consider and fit the schedules of senators who are all over the capital." According to Committee Ranking Member Patty Murray (D-WA), senators would need the extra time to review Gottli...
  • Regulatory NewsRegulatory News

    FDA Commissioner Nominee Faces Limited Opposition From Senate Committee

    The Senate Health, Labor, Education & Pensions Committee on Wednesday offered praise and only a few muted attacks against Scott Gottlieb, President Donald Trump's nominee to be the next commissioner of the US Food and Drug Administration (FDA). While Democrats focused their questions in the hearing on Gottlieb’s conflicts of interest, how he’ll bring down drug prices and solve the opioid crisis, his work as a consultant and employee of pharmaceutical and biotech companie...
  • Regulatory NewsRegulatory News

    Trump Taps Scott Gottlieb to Head FDA

    Dr. Scott Gottlieb, a resident fellow at the American Enterprise Institute (AEI) and former US Food and Drug Administration (FDA) official, has been selected by President Donald Trump to lead FDA as commissioner. The White House confirmed the move on Friday and Gottlieb will face a Senate hearing and vote. A clear front-runner for the position , FDA’s former deputy commissioner for medical and scientific affairs also was recently included in a Centers for Medicare & Med...