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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    Health Canada released a draft guidance document on Tuesday to aid industry in determining whether the agency intends to regulate a software product as software as a medical device (SaMD). Health Canada notified industry last year of its intent to release draft guidance on SaMD as part of a larger initiative to improve regulatory reviews.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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    FDA's Record Year: A Look at 2018 New Drug Approvals

    The US Food and Drug Administration (FDA) set an all-time record for new drug approvals in 2018 with 59 novel drugs and biologics approved by the agency's Center for Drug Evaluation and Research (CDER).   The number of new molecular entities (NMEs) and biologics approved by CDER surpassed the agency's previous record of 53 approvals in 1996 and is a significant jump over the 46 new drugs approved in 2017 . Those figures do not include products approved by FDA's Center...
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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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    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...
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    Health Canada Puts Brakes on SaMD Draft Guidance

    A scientific advisory panel on software as a medical device (SaMD) convened in January by Health Canada caused the agency to hit the brakes on a draft guidance document. The advisory panel, which included the US Food and Drug Administration (FDA), Canada’s medical technology companies (MEDEC), the Council of Canadian Innovators (CCI) and the National Research Council, among others, deliberated on questions Health Canada provided regarding its draft guidance on SaMD ...
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    Senators Urge FDA to Clarify Intentions for Digital Health Pre-Cert Program

    With a proposed deadline of 9 November, three US senators sent a letter to the US Food and Drug Administration (FDA) on Wednesday to request more information on the agency’s pre-certification program for digital health.   FDA’s Center for Devices and Radiological Health (CDRH) recently adapted its regulatory processes to the rapidly evolving nature of digital health, while also encouraging questions like those from Sens. Patty Murray (D-WA), Elizabeth Warren (D-MA)...
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    Updated: New Drug Approvals for FDA: 2017 Hits 21-Year High

    The number of new molecular entities (NMEs) approved by the US Food and Drug Administration (FDA) in 2017 (46 so far, though that number does not include the high-profile CAR-T and gene therapies approved this year) has now topped the all-time high of NMEs approved in any year except 1996. But the record number of approvals comes as experts, including CDER Director Janet Woodcock, have expressed reservations about tracking NME approvals like a horse race, or compari...
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    FDA Backs Off From Regulating Certain Types of Health Software

    The US Food and Drug Administration (FDA) on Thursday unveiled three guidance documents – two draft and one final – that clarify which types of software will be regulated. One of the draft guidances, the 13-page “ Clinical and Patient Decision Support Software ,” outlines which types of clinical decision support software (CDS), which can compare patient-specific signs with available clinical guidelines to recommend treatments, would no longer be defined as a medic...
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    FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

    The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor. The test, referred to as MSK-IMPACT (Integrated Mutation Profiling of Actionable Cancer Targets), was already approved for use with samples from patients in New York by the New York State Department of ...
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    EMA, EUnetHTA Sign Off on Three-Year Work Plan

    The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan. Much of the 2017-2020 work plan builds on previous and ongoing efforts to streamline processes between regulators and health technology assessment (HTA) bodies. "By working together, EMA and EUnetHTA help medicine developers to improve clinical research and become more efficient in...
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    House Adds Provision to Allow DoD to Approve Medical Products Outside of FDA

    The House of Representatives' Rules Committee on Monday will take up a provision that would expand the US Department of Defense's (DoD) ability to approve, on an emergency basis, medical products, as US Food and Drug Administration (FDA) Commissioner Scott Gottlieb pushed for the provision to be rejected. According to the committee's conference report on the National Defense Authorization Act for FY 2018, the House will add the Senate amendment to authorize the s...