• 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...
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    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 ( ...
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    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...
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    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 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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    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...
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    Canadian Regulator and Regulatory Experts to Speak at 2019 Convergence

    RAPS’ 2019 Regulatory Convergence in Philadelphia will include a session hosted by the Canadian Association of Professionals in Regulatory Affairs (CAPRA). RAPS and CAPRA enjoy a collegial relationship and have collaborated on a number of initiatives in recent years. RAPS is even offering CAPRA members the opportunity to attend this year’s Convergence at the RAPS member rate. This is the second consecutive year CAPRA has hosted a session within RAPS’ signature annua...
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    7 Things Attendees Love About the Regulatory Convergence

    RAPS’ signature annual event, the Regulatory Convergence , is a unique opportunity for the regulatory community to gather, reconnect, examine important issues together and exchange ideas face-to-face in a setting completely dedicated to the profession. It is the largest annual conference anywhere in the world for regulatory professionals working in the healthcare product space. For many, it is the one event they prioritize above all others to attend each year. This year...
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    FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD

    The US Food and Drug Administration (FDA) requested feedback Tuesday on a new discussion paper that proposes applying a “focused review” approach to premarket assessments of software as a medical device (SaMD) technologies that are powered by artificial intelligence (AI) and machine learning (ML). The agency said it may conduct a “focused review” in cases where proposed SaMD pre-specifications (SPS) and algorithm change protocols (ACP) “can be refined based on the real-...
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    235 Earn Regulatory Affairs Certification (RAC)

    A total of 235 individuals earned Regulatory Affairs Certification (RAC) during the most recent RAC exam period, RAPS announced today. The challenging RAC exams test essential knowledge of healthcare product regulations, critical thinking and analytical skills. To pass, exam takers must be able to demonstrate not only that they know the relevant regulations, but also how they apply in a variety of realistic scenarios. By passing, each of the 235 professionals now hold ...