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  • Regulatory NewsRegulatory News

    Government Watchdog: FDA Took 'Lax or Permissive' Approach to Pradaxa Approval

    The US Food and Drug Administration's (FDA) judgments regarding the clinical trial and approval of Boehringer Ingelheim's blood thinner Pradaxa (dabigatran) reveal "a lax or permissive approach," according to a new report from the Project On Government Oversight (POGO). Approved by FDA in 2010 to prevent blood clots in patients with atrial fibrillation, POGO chose to investigate the approval of Pradaxa because it's been suspected of contributing to thousands of patient d...
  • 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...
  • Group Calls for Changes to User Fee Bill After Transparency Concerns Emerge

    A group of 20 public interest organizations has written the US Congress to express their displeasure with a measure which would purportedly allow the US Food and Drug Administration (FDA) to hide health and safety inspection information from the public. The group is most concerned about Section 812 of the FDA Reform Act (FDARA) , which they say "allows the FDA to deny the public access to information relating to drugs obtained from a federal, state, local or foreign gov...
  • POGO Lambastes FDA Over Conflict of Interest Report

    The government watchdog group Project on Government Oversight (POGO) has aimed its sights on the US Food and Drug Administration (FDA) over reports that it allowed panelists with potential conflicts of interest to serve as voting members of an advisory committee, even as it took away the voting rights of a vocal critic of the product the advisory committee was voting on.p For further background, please see prior Regulatory Focus coverage here . The group, which calls ...