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  • Regulatory NewsRegulatory News

    Pfizer Appoints Gottlieb to Board of Directors

    Following in the tradition of recently departed US Food and Drug Administration (FDA) commissioners, Scott Gottlieb is joining the board of directors at Pfizer. In addition to his role on the Pfizer board, Gottlieb, an elected member of the National Academy of Medicine, is also resident fellow at the American Enterprise Institute and a partner at the venture capital firm New Enterprise Associates. Reactions to Gottlieb’s decision to join the Pfizer board ranged from ...
  • Regulatory NewsRegulatory News

    Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market

    Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks and clinical trial designs of new drugs and medical devices sped to market without enough preliminary evidence that they are effective. In one of the articles, which evaluated the use of FDA’s accelerated approval pathway, questions were raised on the use of surrogate measures as outc...
  • Regulatory NewsRegulatory News

    Four Former FDA Commissioners: Drug Importation to Reduce Costs is 'Complex and Risky'

    As Congress looks to address the problem of rising prescription drug prices, four former US Food and Drug Administration (FDA) commissioners told members in an open letter from last week that importing cheaper medicines from Canada and elsewhere is "a complex and risky approach." Former commissioners Robert Califf, MD, Margaret  Hamburg, MD, Mark McClellan, MD, PhD and Andrew Von Eschenbach, MD, write that although in some shortage cases, importation of generic dru...
  • Regulatory NewsRegulatory News

    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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    BIO Chair: Trump Should Re-Appoint Califf to Head FDA

    In a phone interview with Focus on Thursday, Ron Cohen, MD, president and CEO of Acorda Therapeutics and chair of industry group BIO, offered his views on increasing funding for the US National Institutes of Health (NIH), what the future may hold for the US Food and Drug Administration (FDA), as well as some new ideas and possible solutions to help contain rising drug prices. NIH and FDA For NIH, Cohen echoed sentiments circulating on Capitol Hill around the 21s...
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    FDA and Industry: How Dangerous is the Revolving Door?

    Earlier this week, a former deputy director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) settled charges that he provided tips on drug approvals to three hedge fund managers that made tens of millions off the non-public information. The settlement raises some important questions on the so-called revolving door between industry and FDA, and what it means for patient safety. Is it OK for those in the pharmaceutical and medical device indust...
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    Senators to FDA: Where are the Alternatives to Mylan’s EpiPen?

    Five senators from both sides of the aisle sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf on Wednesday seeking more information on what the agency is doing to help authorize the use of EpiPen competitors that could bring down the cost of the autoinjector. The letter comes amid a frenzy of Congressional outrage over the more than 400% spike in the price of Mylan’s life-saving EpiPen for those suffering from severe allergies that hasn’...
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    Califf: Advances in Cardiology Will be Made by Integrating New Data Sources and Technologies

    US Food and Drug Administration (FDA) Commissioner Robert Califf is calling on cardiologists to embrace new technologies and data sources, such as genetic sequencing, regenerative medicine, personal electronic devices and social media, in order to improve patient outcomes moving forward. Califf, himself a renowned cardiologist, makes the call in an editorial published in the August edition of the Journal of the American College of Cardiologists . "The FDA is responding...
  • Regulatory NewsRegulatory News

    FDA Commissioner Calls for Better National System to Track Device Safety

    The US needs a better system to quickly detect and understand medical device issues when they arise, US Food and Drug Administration (FDA) Commissioner Robert Califf and Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), wrote in a viewpoint published Monday in JAMA . The call for better postmarket tracking of devices comes as professional societies have developed registries with details on clinical circumstances, procedures and outco...
  • ReconRecon
    Regulatory NewsRegulatory News

    Regulatory Recon: Juno Halts Trial After 3 Deaths Theranos CEO Banned From Running Lab for 2 Years (8 July 2016)

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter. In Focus: US Juno Halts Cancer Trial Using Gene-Altered Cells After 3 Deaths ( Forbes ) ( NY Times ) ( WSJ -$) ( Xconomy ) ( Endpoints ) ( Stat ) ( Fierce ) ( TheStreet ) ( Reuters ) ( Scrip -$) ( In the Pipeline ) ( Press ) FDA Approves Genentech’s Xolair (omalizumab) for Allergic Asthma in Children...
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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 ...