• Regulatory NewsRegulatory News

    What FDA Can and Can’t Do to Help Lower Rising Drug Prices

    Ask any US Food and Drug Administration (FDA) official how the agency can help lower prescription drug prices and you’re likely to hear the same answer: Drug pricing is not under FDA's purview. And sure enough, FDA doesn’t dip its toe into the pricing bog while deciding whether to approve or reject a new drug, and it also doesn’t negotiate with pharmaceutical companies over how to price drugs. But some FDA regulations do have a direct impact on drug prices, and with so...
  • 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’s CDRH Unveils First-Ever Patient Engagement Advisory Committee

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Friday announced the establishment of the first-ever Patient Engagement Advisory Committee (PEAC) to ensure patient needs and experiences are included during the review of medical devices. The committee, which will be made up of nine voting members, one non-voting industry representative and one non-voting consumer representative, will bring together patients, patient a...
  • 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...
  • Regulatory NewsRegulatory News

    FDA: What's Slowing Progress in Some Disease Areas?

    In a post to FDA Voice – the US Food and Drug Administration's blog – recently appointed Deputy Commissioner for Medical Products and Tobacco Robert Califf says progress toward curing some diseases, such as Alzheimer's, is being slowed by a lack of understanding of disease biology. Why are There Effective Treatments for Some Diseases and not Others? Califf raises this question, and points to some diseases like HIV/AIDS, where advances in scientific understanding hav...
  • 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...