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  • Feature ArticlesFeature Articles

    Managing uncertainty: Regulatory reporting in multinational trials during COVID-19

    This article discusses regulatory reporting challenges for multinational clinical trials during the COVID-19 pandemic. The author covers the pandemic’s impact on clinical research, national guidelines, and harmonization, as well as the challenge of assessing what is reportable and how to submit COVID-19 risk mitigation measures. She offers real-world experience on how she and her colleagues stopped and restarted recruitment in ongoing multinational clinical trials, and how...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: EMA shares advice on validated computer systems used in clinical trials

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA shares advice on validated computerized systems used in clinical trials   The European Medicines Agency (EMA) has published a notice about validating and qualifying all types of computerized systems used in clinical trials. EMA released the notice in response to “recent inspection findings” and their implications for the “integrity, reliability, robustness and accep...
  • ReconRecon

    Recon: Abbott beats quarterly profit estimates; UK approves Penlon ventilator for COVID-19

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Chaotic search for coronavirus treatments undermines efforts, experts say ( Washington Post ) House Speaker Pelosi calls Trump WHO decision sen...
  • ReconRecon

    Recon: Merck launches trastuzumab biosimilar in US; Fujifilm boosts Avigan production

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Coronavirus testing hits dramatic slowdown in US ( Politico ) Trump's halt to WHO funding prompts condemnation as coronavirus cases near 2 mill...
  • ReconRecon

    Recon: GSK, Sanofi team up for coronavirus vaccine; India to boost domestic API production

    Editor’s note: Regulatory Recon will be undergoing some changes in the coming weeks as we fine tune its content and presentation to better align with the topics and industries it covers. We value your input as we adapt Recon going forward. Please write to news@raps.org if you have any comments or suggestions.   In Focus: US Trump: It's my decision when to reopen US economy ( Reuters ) ( NPR ) NY, CA and other states plan for reopening as coronavirus crisis eases ( ...
  • Regulatory NewsRegulatory News
    TrackersTrackers

    The Essential List of Regulatory Authorities in Asia

    To ease the process of finding drug and medical device regulators in Asia and Oceania, Focus has updated its list of the website(s) for each country’s ministry of health and regulatory authority. The list also notes the country’s membership in regional organizations that have a regulatory component.   For countries that do not list a regulatory authority, regulatory functions are either performed by the ministry of health, or the information available online was unc...
  • Regulatory NewsRegulatory News

    IMDRF Offers New Guidance on Cybersecurity

    In its first guidance document to deal exclusively with the cybersecurity of medical devices, the International Medical Device Regulators Forum (IMDRF) this week released new general principles and best practices to facilitate better international regulatory convergence on the topic. The 45-page guidance document, developed by a working group led by officials from the US Food and Drug Administration (FDA) and Health Canada, includes both pre-market and post-market cyber...
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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

    APEC Members See Increased Regulatory Convergence

    Countries involved in the Asia-Pacific Economic Cooperation (APEC) are better aligning their regulatory schemes related to drugs and medical devices, according to a new survey unveiled Monday at an APEC meeting in Chile. The survey shows how between 2008 and 2019, APEC countries are seeing modest increases in: Sharing information (from 16 APEC economies to 19 economies) Establishing confidentiality commitments (from 12 economies to 15) Sharing good manufacturing pr...
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    13 Keys to a Successful FDA Advisory Committee Meeting

    When the US Food and Drug Administration (FDA) has significant questions or concerns about clinical data submitted in support of a product under review, it often seeks input from independent academicians and clinicians outside the agency. For this reason, FDA has established Advisory Committees comprised of such experts in various therapeutic areas. Currently, there are 49 such standing committees. If your company is a sponsor of a product subject to Advisory Committee rev...
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    Focus on: Linda Bowen

    Linda Bowen has more than 35 years of experience in the pharmaceutical industry, including 25 in regulatory and the last 12 specifically focusing on regulatory policy and intelligence. She has been an active volunteer with RAPS at both the global and local levels, having served on RAPS’ board of directors, as a chapter chair, and as an expert author, presenter and speaker. She is currently the chair of the planning committee for the 2019 Regulatory Convergence . Linda is ...
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    RAPS AnnouncementsRAPS Announcements

    RAPS Publishes Updated Fundamentals of US Regulatory Affairs Book

    RAPS has just published the updated, 11th edition of Fundamentals of US Regulatory Affairs , the most extensive regulatory affairs textbook available, covering US regulations for pharmaceuticals, medical devices, biologics and related healthcare products. First published 20 years ago, the book has become an important reference for regulatory professionals and others working with healthcare products regulated by the US Food and Drug Administration (FDA) and other US agen...