• Regulatory NewsRegulatory News

    Senators Hint at Confirmation of Califf as Next FDA Commissioner

    Senators on both sides of the aisle offered their support for Robert Califf to be the next commissioner of the US Food and Drug Administration (FDA) at the confirmation hearing Tuesday despite a couple of heated questions on drug pricing and industry’s influence on him. Califf did his best to quell any concerns over industry influencing his decisions as head of the agency and the majority of senators at the hearing seemed confident that his experience makes him the right...
  • Regulatory NewsRegulatory News

    FDA Commissioner Outlines Critical Time Ahead for Agency

    As the US Food and Drug Administration (FDA) transitions between commissioners, continues negotiating industry user fee commitments and prepares for a possible legislative overhaul, a major transformation is in the works for the agency over the next couple of years. FDA Acting Commissioner Stephen Ostroff told attendees on Tuesday at RAPS' Regulatory Convergence that he's seeing an "unusual confluence" of events, particularly as the House-passed  21st Century Cures leg...
  • Regulatory NewsRegulatory News

    President Obama Nominates Califf as Next FDA Commissioner

    President Barack Obama has nominated Robert Califf, the current deputy commissioner for medical products and tobacco at the US Food and Drug Administration (FDA), as the next commissioner of the agency. Califf's History Califf joined the FDA back in February following a stint as vice chancellor of clinical and translational research at Duke University. Other prominent roles during his tenure at Duke include director of the Duke Translational Medicine Institute (DT...
  • RAPS' LatestRAPS' Latest

    Acting FDA Commissioner Stephen Ostroff to Speak at RAPS' Regulatory Convergence

    Acting Commissioner of the US Food and Drug Administration (FDA) Stephen Ostroff , MD, will speak to attendees of the 2015 RAPS Regulatory Convergence . RAPS’ signature annual event for the regulatory profession will take place 24–28 October in Baltimore. Ostroff will speak 27 October, delivering a special keynote address, then he will participate in a panel discussion on key agency activities and initiatives. Other expert panelists are expected to be announced in...
  • Regulatory NewsRegulatory News

    FDA Seeks New Top Press Official for its Office of Media Affairs

    The US Food and Drug Administration (FDA) has started its search for a new leader for its Office of Media Affairs , better known simply as FDA's Press Office. In a job notice posted on 2 March 2015, the agency said it's looking for a new assistant commissioner for media affairs—a position which has long been in a state of flux. The office is currently overseen by Acting Assistant Commissioner Heidi Rebello, who took over from former Acting Assistant Commissioner Eric...
  • Regulatory NewsRegulatory News

    Charts: Who are the Longest-Serving Commissioners in FDA History?

    On 5 February 2015, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced she would resign from her position in March 2015. This caused us to wonder: How long will Hamburg have served when she steps down from her position, and how does that compare with other FDA Commissioners before her? As we found, Hamburg will be the sixth-longest serving Commissioner in FDA history, and the second-longest-serving commissioner of the modern regulatory era...
  • Regulatory NewsRegulatory News

    FDA Hires World-Renowned Cardiologist to Oversee Medical and Regulatory Policy

    One of the world's top cardiologists is set to join the US Food and Drug Administration (FDA) next month to oversee four of its largest regulatory divisions, FDA Commissioner Margaret Hamburg has announced. In a 26 January 2014 announcement, Hamburg said FDA had appointed Robert Califf as deputy commissioner for Medical Products and Tobacco. Califf is a familiar figure to many within the life sciences field. He is currently the director of the Duke Translational Medici...
  • Regulatory NewsRegulatory News

    FDA Quietly Announces Creation of New Regulatory Division, Search Begins for Leader

    The US Food and Drug Administration (FDA) is looking to hire a high-level regulatory official to lead the agency's brand new division of Regulatory Affairs Strategic Management (RASM), it announced this week. The position, for a deputy associate commissioner, was recently created "to respond to significant changes in the regulated industry" and FDA's scope of authority, the agency said in its job posting for the position. Explained FDA: "These changes includ...
  • With NDA on the Line, Company Hires Former FDA Commissioner to Head up Regulatory Team

    With a new drug approval decision on the line, one struggling company's regulatory affairs team is about to get a new employee with an impressive formal title: commissioner of the US Food and Drug Administration (FDA). Background The company in question is Braeburn Pharmaceuticals, a New Jersey-based pharmaceutical company involved in development therapies to treat addiction, which said in a statement that it had hired Frank E. Young as executive vice president of clini...
  • Tonio Borg Likely Replacement for European Commission's Dalli

    It's official: Tonio Borg has been nominated as the successor to EU Health Commissioner John Dalli , who resigned last month after a scandal involving his agency's treatment of pending tobacco legislation, and will appear before EU legislators in several days for a hearing. Under European Commission (EC) rules, the replacement to a relinquished post must go to a person from the same country. Borg, a native of Malta like Dalli, currently serves as the country's deputy pr...
  • EU Health Commissioner John Dalli Forced out in Wake of Fraud Probe

    The EU's Health Commissioner, John Dalli, has resigned from the European Commission (EC) following an investigation into his handling of a review of a policy on tobacco-the latest black mark for EU health regulators who have seen a number of high-profile scandals and resignations in the past two years. In the press statement , the EC said Dalli's resignation followed a complaint made by Swedish Match, a tobacco manufacturer which claimed Dalli had traded favors with a M...
  • Former FDA Commissioner Calls for Agency Reforms

    The former Commissioner of the US Food and Drug Administration (FDA), Andrew von Eschenbach, has more than a few ideas about improvements that could be made to the agency he used to lead. In a series of articles, Eschenbach, now with The Manhattan Institute's Project FDA, has argued on behalf of making some potentially radical changes at the agency. In a February 2011 Wall Street Journal opinion piece , Eschenbach argued on behalf of a safety-based approval system in...