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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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    Industry Seeks Cross-Center Alignment in FDA Proposal on Prescription Drug Software

    The US Food and Drug Administration’s (FDA) regulation of prescription drug-use-related software (PDURS) behooves alignment across relevant centers, industry comments on FDA’s proposed framework argued. From pharmaceutical companies and trade associations to digital health companies and coalitions, the agency’s November 2018 proposed framework for the future regulation of PDURS drew comments from a range of stakeholders. The proposed framework  on PDURS is largely seen...
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    AdvaMed Responds to Senator’s Call to Advance Cybersecurity

    Responding to a letter from Sen. Mark Warner (D-VA) that called for a collaborative effort to advance cybersecurity in health care, medical device industry group AdvaMed sought to ease concerns about the impact of cyber attacks with updates on industry and regulators’ moves in line with its five principles. The industry trade association’s board of directors adopted the set of five medical device cybersecurity principles in 2017 to drive best practices across its member...
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    WHO Panel Calls for Global Gene Editing Registry

    The World Health Organization’s (WHO) newly-formed advisory panel on human genome editing is calling for the creation of a central registry for all human genome editing studies following a two-day meeting that concluded in Geneva on Tuesday.   WHO established the panel in December following reports that Chinese scientist He Jiankui had modified the genomes of a pair of twin girls to make them resistant to HIV infection. Jiankui’s claims prompted swift international b...
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    HHS Floats Digital Health PreCert Approach as CDRH Limits Pilot Participation

    In a proposed rule from the US Department of Health and Human Services (HHS), the agency is seeking input on whether to expand on the US Food and Drug Administration’s (FDA) digital health pre-certification (PreCert) program for purposes of health IT certification. Yet FDA has said it will limit PreCert participation, for now. The 724-page proposed rule was unveiled on Monday by HHS’s Office of the National Coordinator for Health Information Technology (ONC). The move h...
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    Health Canada Seeks to Better Define Regulatory Requirements for SaMD

    Health Canada released a draft guidance document on Tuesday to aid industry in determining whether the agency intends to regulate a software product as software as a medical device (SaMD). Health Canada notified industry last year of its intent to release draft guidance on SaMD as part of a larger initiative to improve regulatory reviews. The timeline, however, was delayed after a Health Canada scientific advisory panel raised concerns over the previous approach, whic...
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    Cybersecurity: FDA, Industry Groups Welcome Joint Plan

    The Healthcare and Public Health Sector Coordinating Council (HSCC) released a new medical device and health IT joint security plan (JSP) Monday to serve as a reference guide for strengthened cybersecurity. Industry-driven public-private partnership HSCC developed the new JSP in response to 2017 recommendations from the Health Care Industry Cybersecurity Task Force. It specifically addresses the second imperative identified by the task force—increase the security and re...
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    UK Details Plans to Tackle Antimicrobial Resistance Over the Next 20 Years

    The UK's Department of Health and Social Care on Thursday released two policy papers detailing the actions the government plans to address antimicrobial resistance (AMR) over the next five years and a global vision for containing AMR by 2040.   Speaking at the World Economic Forum in Davos Switzerland on Thursday, UK Health Secretary Matt Hancock called AMR "as big a danger to humanity as climate change or warfare," and called for an "urgent global response."   Whi...
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    Patient Experience Data: FDA Drafts Guidance

    Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday published new draft guidance to help stakeholders submit a proposed draft guidance on patient experience data. The 12-page draft guidance, which provides information in a Q&A format, addresses questions relating to both guidance development and other potential pathways for contributing patient experience data. “Today’s guidance document is part of our commitment to advance p...
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    Woodcock Lays Out Top CDER Priorities for 2019

    While noting that the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has reached some important milestones in 2018, CDER Director Janet Woodcock also unveiled the center’s priorities for 2019 at the CMS/FDA Summit in Washington, D.C. on Tuesday. “We’ve generally accomplished what we set out to do” in 2018, she said, noting that in the generic drug space, “we’ve reached a steady state,” while in the new molecular entity (NME) space...
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    EMA, Health Canada to Tighten Alliance Around Mutual GMP Inspections

    Though the European Medicines Agency (EMA) and Canada have had a mutual recognition agreement (MRA) in operation since February 2003, both sides announced Monday that they may further strengthen their ties. On Friday, the European Commission’s DG Sante, EMA and Health Canada held the first Joint Sectoral Group (JSG) on Pharmaceuticals, which is a specialized committee established under the Committee on Trade in Goods of the Comprehensive Economic and Trade Agreement (CE...
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    WHO Finds Wide Disparities in Antibiotic Use Between Countries

    A new report from the World Health Organization (WHO) published Monday reveals major differences in the amount of antibiotics consumed by countries around the world and calls for changes in how countries monitor and use antimicrobial drugs.   “Overuse and misuse of antibiotics are the leading causes of antimicrobial resistance. Without effective antibiotics and other antimicrobials, we will lose our ability to treat common infections like pneumonia,” said Suzanne Hill,...