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  • Feature ArticlesFeature Articles

    Project Teams for Regulatory Advisory Committees

    Imagine the end of a voyage. The ship bobs a few feet from the dock. A crowd awaits cargo, and everyone aboard yearns for shore. Now imagine the decision about whether the journey is ended is not yours to make. Imagine you must argue publicly the merits of your journey and the status of your cargo. Your debate is not with those on the journey or those met en route, but with experts on journeys and cargo. They vote after discussion. Everyone waits, on both sides of the doc...
  • Group Claims FDA Being Overly Secretive with Advisory Committee Member Information

    The US Food and Drug Administration (FDA) is being unnecessarily opaque with some information related to its advisory committee members, a prominent consumer group charged this week. Background In addition to FDA's own regulatory staff, it is assisted in its review of new medicines and regulatory decision making by advisory committees composed of subject matter experts. Those committees give FDA advice that, while non-binding, is followed by the agency in the majority o...
  • Process of Joining FDA's Advisory Committees Becomes (A Little Bit) Easier

    It's about to become a little bit easier to become a member of the US Food and Drug Administration's (FDA) Advisory Committees, the agency said today. No, FDA isn't relaxing its standards for admittance to the committees-those are staying the same. What is changing is the way in which nominations are seen by the public and submissions are sent to the agency. In a 22 January 2014 announcement , FDA said it had launched an advisory committee membership nomination portal...
  • February to see Flurry of FDA Advisory Committee Meetings

    Even by the usual standards of the US Food and Drug Administration (FDA), it has been an unusually busy week for announcing advisory committee meetings. The committees, which offer regulators non-binding but influential advice that is generally followed, are often called upon to either assess new products or niche problems requiring specialized or public input. This week has already seen a flurry of announcements for upcoming advisory committee meetings, with no fewer t...
  • FDA Extends Comment Period on Cell and Gene Therapy Guidance by Six Months

    Manufacturers of cell therapy (CT) and gene therapy (GT) products will have six months of additional time to comment on a July 2013 draft guidance released by the US Food and Drug Administration (FDA), regulators announced today. Background In July 2013, FDA's Center for Biologics Evaluation and Research (CBER) released a draft guidance it said would help industry in designing early-stage clinical trials for CTs and GTs. The guidance was specifically aimed at investiga...
  • Feature ArticlesFeature Articles

    Improving Public Participation and Transparency at FDA with Earlier Availability of Advisory Committee Materials

    In 2009, facing a 2,000 mile journey to a US Department of Health & Human Services (DHHS) Advisory Committee meeting, a representative of a patient organization struggled with others to prepare for the open public hearing portion of the meeting. There simply was not enough information about the meeting agenda in the Federal Register "to understand what is happening and prepare [public] testimony," he told the Advisory Committee, and he did not receive a full agenda ...
  • FDA Calls on Public to Fill Dozens of Open Device-Related Advisory Committee Seats

    The US Food and Drug Administration (FDA) is calling for the nomination of new voting members to serve on several of its medical device-related public advisory committees, saying it will accept nominations for all current vacancies as well as those to occur before the end of 2013. The committees include the Device Good Manufacturing Practice Advisory Committee, as well as device-related panels of the Medical Devices Advisory Committee, the National Mammography Quality ...
  • Does Advisory Committee Transparency Lead to Better Regulatory Decision Making?

    The US Food and Drug Administration (FDA) often courts controversy with its decisions to approve or deny new therapies. In the wake of some high-profile scandals in the past decade, the agency has made its regulatory processes more transparent by opening up its advisory committees to more public input and fewer potential conflicts of interest. But, until now, few have asked a simple question: Are those changes leading to improved regulatory outcomes? A new book, Regul...
  • Consumer Advocacy Group Fires Back at FDA Over Transparency of Advisory Committees

    The consumer advocacy group Project on Government Oversight (POGO) is re-engaging the US Food and Drug Administration (FDA) on whether a panel of experts convened by the agency to review the safety of a class of oral contraceptives was sufficiently independent of conflicts of interest. The entire incident is the result of a January 2012 investigation by the Wall Street Journal into an FDA advisory committee charged with reviewing birth control products containing dro...
  • FDA Advisory Committee to Assess 'Warning Fatigue'

    An advisory committee meeting convened on behalf of the US Food and Drug Administration (FDA) is set to discuss factors influencing the communication concerning regulated healthcare products, including pharmaceuticals, medical devices and biologics, FDA announced in the Federal Register . FDA's Risk Communication Advisory Committee (RCAC) is set to meet on 2 November 2012 to discuss the topic of message fatigue, warning fatigue and "inaccurate risk perception," all ...
  • FDA Seeks Industry Nominees for Pediatric Advisory Committee

    The US Food and Drug Administration (FDA) is calling on the pharmaceutical and medical device industry to nominate a nonvoting industry representative to serve on the Pediatric Advisory Committee. In its 9 August Federal Register posting, FDA notes the nominee, "May either be self-nominated or nominated by an organization to serve as a nonvoting industry representative." The committee oversees research priorities, ethical considerations and pediatric drugs, biologics, ...
  • FDA Staff Expresses Caution Regarding Approval of Edwards' Sapien Heart Valve

    Review staff from the US Food and Drug Administration (FDA) said Edwards Lifesciences' Sapien Transcatheter Heart Valve (THV) met trial endpoints for safety and effectiveness for the treatment of high-risk severe aortic stenosis, but expressed concern about trial biases, long-term risks to patients and the statistical validity of some of Edwards' findings. Edwards' device is set to go before a meeting of the Circulatory Systems Advisory Committee on 13 June, where Edward...