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    RAPS AnnouncementsRAPS Announcements

    RAPS Honors Winners of Founder’s Award, Community Leadership Award and New Patient-Centered Health Award

    RAPS today recognized five distinguished individuals and one leading advocacy organization for contributions to the regulatory profession and to promoting public health.   “The Founder’s Award is RAPS’ highest honor,” said RAPS Executive Director Paul Brooks. “It recognizes exemplary professionals who have had a substantial and sustained impact over the course of their careers, shaping regulatory policy and practice, and advancing the regulatory profession.”   The ...
  • Regulatory NewsRegulatory News

    Real World Evidence: Can it Support New Indications, Label Expansions?

    At a public workshop in Washington, DC last week, top US Food and Drug Administration (FDA) officials and other experts explored the challenges and opportunities surrounding real world evidence (RWE) in regulatory decision making. The question they sought to answer is whether data gathered from healthcare systems can be used to supplement or support regulatory decisions, such as the approval of new indications or label expansions for existing drugs. FDA currently uses r...
  • FDA Releases Long-Awaited Draft Guidance on Clinical Trials

    The US Food and Drug Administration (FDA) has released an extensive new guidance document that one of its top drug regulatory officials says is aimed at "greatly increase[ing] the likelihood that data collected during a clinical trial will demonstrate that an effective drug is effective." Writing in a blog posting on the FDA Voice blog on 17 December 2012, FDA's Bob Temple, deputy director for clinical science at the Center for Drug Evaluation and Research (CDER), sa...
  • Temple: FDA in Process of Writing Guidance on Boosting Clinical Effectiveness

    The US Food and Drug Administration's Deputy Director for Clinical Science, Bob Temple, often referred to as the agency's " dean of drug development ," has announced the development of a new guidance on finding study populations in which a drug can be properly evaluated. Writing on the Center for Drug Evaluation and Research's (CDER) website on 21 June, Temple described "enrichment design studies"-attempts to boost the clarity of a clinical trial's data by selecting a pa...
  • Advisory Committee Votes Against Label Expansion for J&J/Bayer's Xarelto

    The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted against Johnson & Johnson and Bayer's co-developed oral anticoagulant drug Xarelto (rivaroxaban), which the companies were looking to market as a therapy for Acute Coronary Syndrome (ACS). Xarelto is already FDA-approved for reducing the risk of blood clots in limited populations. The advisory committee had expressed some doubts regarding the drug on 22 May, saying m...
  • FDA's Bob Temple Moving from ODE-1 to Other Position

    Bob Temple, the US Food and Drug Administration's (FDA) Director of the Office of Drug Evaluation 1 (ODE-1), is fully assuming his role as Deputy Center Director for Clinical Science and giving up his role as the ODE-1 director, reports BioCentury . Temple was first promoted to the position of Deputy Center Director in November 2009, but has remained in ODE-1. Prior to ODE-1, Temple worked in the Office of Medical Policy, which oversaw the then-named Division of Dru...