• Regulatory NewsRegulatory News

    FDA Approves First Generic Naloxone Nasal Spray for Opioid Overdose Treatment

    Teva Pharmaceuticals USA snagged US Food and Drug Administration (FDA) final approval for the first generic naloxone hydrochloride nasal spray known as Narcan, the agency announced on Friday. The life-saving medication is indicated for stopping or reversing the effects of an opioid overdose and the approval forms part of the agency’s ongoing efforts to combat the nation’s opioid crisis. Generic injectable naloxone products are already in use at health care settings, but...
  • Regulatory NewsRegulatory News

    Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH

    In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition. The comment period for feedback on the VCS program FDA’s Center for Drug Evaluation and Research (CDER) proposed via its February draft guidance closed earlier this week, with submissions from several standards development organizations (SDOs) and others. SDOs, in general...
  • Regulatory NewsRegulatory News

    CDRH Draft Guidance Tackles Nitinol Devices

    As part of a broader effort to address potential safety issues from materials in medical devices, the US Food and Drug Administration (FDA) proposed technical considerations for nitinol-containing devices. The draft guidance FDA’s Center for Devices and Radiological Health (CDRH) issued on Thursday covers the types of information to include in premarket submissions of devices made from nitinol, including material composition and manufacturing parameters, pseudoelasticit...
  • Regulatory NewsRegulatory News

    CDRH Drafts Guidance on Quantitative Imaging

    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday. CDRH’s proposed recommendations cover the device’s functional description, technical performance assessment and labeling/user information. For devices that include quantitative imaging functions, th...
  • Regulatory NewsRegulatory News

    MedTech Europe Warns Over ‘Untenable’ Transition to EU MDR/IVDR

    MedTech Europe sent an open letter to the European Commission (EC) on Monday to urge immediate action on implementing the new medical device and IVD regulations as the transition is becoming “clearly untenable.” The letter from the trade association’s CEO Serge Bernasconi underscores the growing urgency and need for the EC and member states to finish what they started in 2017 with the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR). The letter highl...
  • Regulatory NewsRegulatory News

    WHO Releases First Guideline on Digital Health Interventions

    The World Health Organization (WHO) on Wednesday released a first-of-its-kind guideline on 10 ways for countries to apply digital health interventions across the health system while avoiding potential detrimental effects. The 10 recommendations are detailed in the UN agency’s 124-page guideline for strengthening health systems through the appropriate implementation of digital health. The focus of the guideline is currently limited to digital health technologies that can...
  • Regulatory NewsRegulatory News

    Experts Tell Device Companies Not to Fret Over QMS Transition

    Ahead of the proposed shift away from the current US Food and Drug Administration (FDA) quality management system (QMS) CFR 21 Part 820 regulation toward ISO 13485:2016, a new white paper sheds light on how the action will impact medical device development. The white paper identified three interrelated principles that will define the direction of the agency’s process, which has yet to be clearly defined, after the transition . These principles relate to the concept of ...
  • Regulatory NewsRegulatory News

    GAO Identifies Gaps in FDA's Office of International Programs

    US Food and Drug Administration (FDA) Commissioner Ned Sharpless “should assess the effectiveness of the foreign offices’ contributions,” a Government Accountability Office (GAO) report recommended. GAO’s report called attention Thursday to priority recommendations on FDA’s parent agency, the US Department of Health and Human Services (HHS). As the agency continues testing performance metrics and evaluating the strategic workplan of its Office of International...
  • Regulatory NewsRegulatory News

    WHO Drafts Global Strategy on Digital Health

    The World Health Organization (WHO) released a newly drafted four-year global strategy on digital health, with an aim to “improve health for everyone, everywhere by accelerating the adoption of appropriate digital health.” As more health care delivery systems look to digital health to address emerging challenges, such as the rise of noncommunicable diseases, clinician workforce shortages and the aging population, barriers to the adoption and application of such tools pe...
  • Regulatory NewsRegulatory News

    Australia Unveils Device Action Plan

    Australia’s Therapeutic Goods Administration (TGA) released a three-part medical device action plan, part of which will make adverse event reports more timely, as well as enhance public awareness on and the agency and device regulatory system. The plan also identifies additional opportunities for TGA to increase transparency, with stakeholder consultations on proposed changes to regulatory requirements and forthcoming guidance materials. Until early 2020, potential c...
  • Regulatory NewsRegulatory News

    Q&A: Why Seven Regulators Use One Company’s Software for Drug and Biologics Reviews

    To streamline decision-making in approval processes, three regulatory authorities joined four others Thursday in increasing their adoption of drug development consultancy Certara’s Phoenix platform. The UK’s Medicines and Healthcare products Agency (MHRA), Brazil’s National Health Surveillance Agency (ANVISA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) are now licensing Certara’s Phoenix IVIVC toolkit for in vitro-in vivo correlation. The agencies wer...
  • Regulatory NewsRegulatory News

    FDA’s De Novo Program Gains Momentum

    The US Food and Drug Administration (FDA) has been steadily increasing the annual number of granted de novo classification requests in recent years and hit a record of 44 de novos granted during 2018. The de novo premarket review pathway, used for novel, low-to-moderate-risk devices that are not substantially equivalent to already marketed devices, has increasingly attracted interest in the medical device ecosystem, particularly after the quick turnaround for Apple’s g...