• Regulatory NewsRegulatory News

    European Regulatory Roundup: Dutch Regulator Revamps Drug Nomenclature Policy (22 October 2015)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Dutch Regulator Overhauls Policy on Nomenclature of Medicines The Medicines Evaluation Board (MEB) in the Netherlands has completely revised its policy on nomenclature covering human medicinal products and is enforcing the changes with immediate effect. Out of all the revisions included in the new nomenclature policy, MEB has picked out six that it sees as the most importan...
  • 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...