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    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...
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    Trump’s FDA Commissioner Choice Coming Soon

    Dr. Tom Price, secretary of the US Department of Health and Human Services, said in an interview this week that the new commissioner for the US Food and Drug Administration (FDA) and other health-related political appointees should be announced in the next week or so. Price, speaking on the Hugh Hewitt show on Monday, said : “I’ve got 18 Senate-approved, presidential-appointed, Senate-approved folks in my department, and we’ve got virtually all of them with names that ...
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    Potential Trump FDA Commissioner Choice: A Q&A With Dr. Joseph Gulfo

    A potential President Donald Trump choice for US Food and Drug Administration (FDA) commissioner spoke with Focus on Tuesday. Here’s a lightly edited version of the interview with Dr. Joseph Gulfo, the executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, the author of “Innovation Breakdown: How the FDA and Wall Street Cripple Medical Advances” and the former President and CEO of the medical device firm ME...
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    Outgoing FDA Commissioner Califf on Benefit-Risk Assessments and Advisory Committees

    Writing in JAMA and FDA’s Voice blog late this week, outgoing US Food and Drug Administration (FDA) commissioner Robert Califf took to task any doubters on the necessity of an independent FDA that can assess an investigational drug’s safety and efficacy. “Some argue that individuals and their physicians should be free to make these decisions without relying on FDA to make determinations about marketing approval. However, the complexity of the data as well as examples ...
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    Politicizing the FDA: What the Trump Win Means for New Pharma Regulations

    President-elect Donald Trump on Friday will become the 45th US president, and though he’s yet to name his choice for commissioner of the US Food and Drug Administration (FDA), the names of those floated to lead the agency and a recent flood of new draft and finalized FDA guidance reveal an agency bracing for change. Since 7 November, FDA has released almost 20 new draft or revised draft guidance documents, some long-awaited, like the one on biosimilar interchangeabil...
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    FDA Commissioner Listed in CMS Database for Receiving Payments from GSK, AstraZeneca in 2015

    In what might turn out to be an odd mistake, the current US Food and Drug Administration (FDA) Commissioner Rob Califf was included in a database of pharmaceutical company payments to physicians updated by the US Centers for Medicare & Medicaid Services (CMS) on Thursday. The database says Califf received five payments from GlaxoSmithKline for travel, lodging, food and beverages, as well as a more than $5,000 consulting fee from AstraZeneca in 2015. In 2014, when he ...
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    2015 Regulatory Convergence Highlights: Stephen Ostroff's Keynote

    One of the big draws of attending RAPS’ annual Regulatory Convergence is the opportunity to hear directly from regulators. Each year, the Convergence features dozens of speakers and panelists representing global regulatory agencies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the China Food and Drug Administration and many others. Among the highlights of last year’s Convergence in Baltimore was the opportu...
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    New Report Calls on FDA to Clarify Use of Real-World Evidence

    As legislation to speed the process by which the US Food and Drug Administration (FDA) approves new drugs and devices continues to stall in Congress, mostly because of disagreement over funding for the National Institutes of Health (NIH) and patient safety concerns, a nonprofit on Thursday released a new report calling for FDA to clarify ways real-world evidence can be used to support clinical trials and postmarket commitments. The Bipartisan Policy Center’s 32-page repo...
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    Senate Confirms Califf as Next FDA Commissioner

    The US Senate on Tuesday voted 89 to 4 to confirm Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA). Califf's path to confirmation was made clear after a procedural vote Monday evening, when senators voted 80 to 6 to move the nomination to a vote. In September, President Barack Obama nominated Califf to replace Margaret Hamburg, who resigned in March after leading FDA for six years and was replaced in th...
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    Updated: Califf Headed for Confirmation as Next FDA Commissioner

    Only six senators voted against Robert Califf in a procedural vote late Monday setting up a final vote for his appointment as the next commissioner of the US Food and Drug Administration. On Tuesday, a handful of senators continued to criticize FDA over their opioid approvals, though these criticisms are not expected to halt Califf's confirmation. The positive vote on Monday for the former Duke University cardiologist and clinical trials expert also came after an hour of...
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    Senate HELP Committee Votes in Favor of Califf for FDA Commissioner

    The US Senate Committee on Health, Education Labor & Pensions (HELP) on Tuesday voted in favor of letting the full Senate vote to approve Robert Califf as the next Food and Drug Administration (FDA) commissioner. HELP Committee Chairman Lamar Alexander (R-TN) called Califf “the right man to lead the FDA,” as others offered their support. Sen. Lisa Murkowski (R-AK), who said back in November she would put a hold on Califf’s nomination, said at the hearing that she “g...
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    EMA Investigating Validity of Clinical Trial Led by FDA Commissioner Nominee

    The European Medicines Agency (EMA) has told Focus that it’s currently investigating whether a medical device defect may have had an impact on a major clinical trial that was designed and overseen by FDA commissioner nominee Robert Califf and ultimately led to the drug’s FDA and EMA approvals. The trial , which compared the anti-clotting drug Xarelto (rivaroxaban) for patients with irregular heartbeat with warfarin, used an INR (International Normalized Ratio) device ...