RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Feature ArticlesFeature Articles

    Making the transition from regulatory manager to regulatory consultant

    This article is about making the transition from company-based regulatory management to regulatory consultancy. It describes the differences between the two roles and provides hands-on, detailed guidance on best practices and how to prepare and tool up for consulting. The author presents a case study demonstrating step by step how a consultant drew on those practices and tools to assist an overseas client in successfully marketing an existing medical device in the US.   ...
  • Feature ArticlesFeature Articles

    US-focused regulatory toolbox: The basics

    This article examines regulatory tools found mostly on the US Food and Drug Administration’s (FDA’s) website for use by regulatory affairs professionals interested in drug products and medical devices marketed in the United States.   FDA guidance documents 1 Guidance documents represent the agency’s current thinking or interpretation of a particular policy or topic. They are an especially useful tool for RA professionals dealing with issues such as drug development ...
  • RoundupsRoundups

    Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluation of COVID-19 vaccines

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published principles for evaluating COVID-19 vaccines. The principles echo guidelines published in other parts of the world, for example by recommending that studies are designed to show vaccines prevent COVID-19.   PMDA, like its peers, is against the use of surrogate measures given the lack of evidence linking them to the key endpoint of COVID-19 prevention. Clinical trials to assess the preventive effect ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS’ updated book on regulatory strategy for devices serves as ‘how to’ guide

    Constant innovation in medical technology, globalization, pressure on medical device makers to control costs and demonstrate clear benefits to patients, and increased scrutiny from regulators make having a sound regulatory strategy more critical than ever. The recently released second edition of RAPS’ Global Medical Device Regulatory Strategy book provides a “how to" guide to developing a comprehensive regulatory strategy for bringing all types of devices to the global...
  • Feature ArticlesFeature Articles

    Human microbiomes in health and disease: Strategic options for regulatory science and healthcare policy

    This article describes the human microbiota and microbiomes’ strategic role in personalizing health and disease management, which is rapidly demanding diligent regulatory science and policy action to ascertain confidence and trust among consumers, patients, and healthcare providers. The authors discuss why establishing harmonized processes and standards to better understand the baseline healthy microbiota is essential to development of strategies for nutrition and clinical...
  • Regulatory NewsRegulatory News

    Asia-Pacific Regulatory Roundup: TGA grants provisional approval to Gilead’s COVID-19 drug remdesivir

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional approval to Gilead Sciences’ remdesivir for use in adults and adolescents hospitalized with severe COVID-19 symptoms.   Like its international peers, TGA sought to fast track its review of remdesivir to get the antiviral to patients as quickly as possible. TGA said it made a decision within two weeks of receiving a filing for approval of the drug, which is sold under the brand name Veklury, by h...
  • 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...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA orders re-evaluation of COVID-19 antibody studies amid false negative concerns

    Australia’s Therapeutic Goods Administration (TGA) has asked the sponsors of point-of-care tests for antibodies against the SARS-CoV-2 coronavirus to re-evaluate their clinical performance studies. TGA made the request after reviewing the findings of a postmarket evaluation carried out by a third party.   The Onsite and VivaDiag tests, which are made by CTK Biotech and VivaChek Biotech, respectively, came to market with instructions for use that quoted sensitivity figu...
  • 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 ( ...