• Regulatory NewsRegulatory News

    Industry Supports FDA Proposal to Create New Office of Patient Affairs

    Industry groups BIO and TransCelerate, as well as companies GlaxoSmithKline and Shire, have offered their support for the creation of a new office at the US Food and Drug Administration (FDA) focused on patient affairs. The idea for the new Office of Patient Affairs (OPA), proposed in March , is part of the agency’s efforts to offer "a single, central entry point to the Agency for the patient community," as well as "triage and navigation services for inbound inquir...
  • Regulatory NewsRegulatory News

    FDA, NIH & Industry Advance Templates for Clinical Trial Protocols

    • 03 May 2017
    The US Food and Drug Administration (FDA) and National Institutes of Health (NIH) on Tuesday released the final version of a common template for clinical trial protocols intended to save sponsors of NIH-funded Phase II and III studies both time and money. "The FDA and NIH see protocol harmonization as an essential component to the accelerated delivery of medicines to patients. Having aligned templates will help enable health authorities to receive consistent, high-qualit...
  • Regulatory NewsRegulatory News

    TransCelerate Progress on Trial Efficiencies Unimpeded by Pharma Regulators

    The joint efforts of 18 biopharmaceutical companies, under the umbrella of TransCelerate BioPharma, are continuing to advance their efforts in sharing data, making clinical trials more efficient and working with drug regulators around the world to ensure that progress enables change that can help patients. The group is working to leverage the data and best practices of its members, such as Pfizer, Amgen, AstraZeneca, Merck and Roche, across a wide swath of trial-relate...
  • Major Pharmaceutical Companies Join Together to Address Regulatory Challenges

    • 19 September 2012
    Ten of the world's largest biopharmaceutical companies have banded together to find ways to solve what the group is calling, "common drug development challenges," including the improvement of the quality of clinical studies. The companies-Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, Johnson & Johnson, Pfizer, Genentech a member of the Roche Group, and Sanofi- announced the formation of a nonprofit entity cal...