FDA News

  • August 18, 2017

    Review Finds UK Universities Not Reporting Clinical Trial Results

    A review conducted by TranspariMED found the top 16 UK medical universities have posted results for only 5.8 percent of 3,540 clinical trials that had been completed in 2015.
  • August 18, 2017

    FDA Issues MAPP on Emergency IND Process

    The Center for Drug Evaluation and Research’s Office of New Drugs released a Manual of Policies and Procedures (MAPP) 6030.3 on Aug. 15 on the emergency Investigational New Drug application process during and after normal business hours
  • August 18, 2017

    Study Finds Number of Exclusion Criteria Growing in Lung Cancer Trials

    An examination of 30 years of lung cancer clinical trials sponsored or endorsed by the Eastern Cooperative Oncology Group (ECOG) found a nearly 60 percent increase in exclusion criteria.

  • August 18, 2017

    FDA Opens Public Comment on Communicating Risk Info in DTC Broadcast Ads for Drugs and Biologics

    The FDA established a public docket to get stakeholder comment on the development of recommendations regarding the communication of risk information in direct-to-consumer (DTC) broadcast advertisements for prescription drugs and biologics.

  • August 18, 2017

    IRBs Need To Rethink Payments to Research Subjects

    Institutional Review Boards (IRBs) need to reset their thinking on payments to research participants, according to an article in IRB: Ethics & Human Research.
  • August 18, 2017

    JAMA Articles Raise Concerns About FDA Not Requiring RCTs in Some Cases

    Two studies posted by JAMA Aug. 15, “raise concerns about whether the U.S. regulatory system has become too permissive by not requiring traditional randomized controlled trials (RCTs) for postmarketing evaluation of drugs approved through the accelerated approval pathway and for supplemental design modifications of medical devices thought to be sufficiently risky to warrant human studies,” according to an accompanying editorial by former FDA commissioner Robert Califf.
  • August 18, 2017

    PhRMA Says FDA Needs Clear Research Agenda Regarding Advertising and Promotion Studies

    Noting the FDA has proposed at least 22 research studies concerning prescription drug advertising and promotion in the past five years, the Pharmaceutical Research and Manufacturers of America (PhRMA) said it is concerned the agency “has proposed to undertake projects in a variety of disparate topics without articulating a clear, overarching research agenda or adequate rationales on how the proposed research related to the goal of further protecting public health.”


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