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    LPAD pathway: FDA finalizes guidance

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance explaining its recently created program intended to spur the development of new antibiotic and antifungal drugs intended for limited patient populations.   The final guidance comes more than two years after FDA issued the draft guidance for comment and a year after the agency held a public meeting to receive input on the guidance from the scientific community. (RELATED: FDA details limited ...
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    Canada’s drug price reforms delayed to 2021

    Amendments to Canada’s Patented Medicines Regulations will now be put in place 1 January 2021, delaying implementation of the sweeping drug pricing reforms by six months.   The new timeline represents a further adjustment from the schedule laid out in 2017, when Health Canada first proposed overhauling its drug pricing review process.   Draft pricing guidelines promulgated by the government of Canada’s Patent Medicine Prices Review Board (PMPRB) have been availab...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 25 February 2020 to include: Vifor Pharma said on 17 February that it p...
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    Researchers Estimate Costs of Exclusivity Extensions to Encourage Antibiotic Development

    A bill introduced last year in the US House of Representatives that would reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers could end up costing public and private payers $4.5 billion over 10 years, Harvard Medical School researchers said in an article published Sunday. The economic impact of the bill, which was introduced by Rep. John Shimkus (R-IL), who is not seeking re-election, and co-sponsored by two Democrats, was ...
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    FDA Explains What Mobile Apps Are No Longer Devices

    A section of the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and removed certain software functions from the definition of a medical device. In addition to drafting new guidance on clinical decision support software, the US Food and Drug Administration (FDA) on Thursday released final guidance explaining what digital health products are no longer devices and are no longer subject to FDA regulations. Examples of such...
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    Health Canada’s Public Release of Drug, Device Clinical Data Picks Up Steam

    Last March, amendments to Canada’s  Food and Drug Regulations and the Medical Devices Regulations enabled the public release of clinical information submitted to Health Canada for new drug and device approvals. But in the first five months after the amendments took effect, just one clinical trial package for a new drug and one clinical trial package for a new device were published. In the last two months, however, Health Canada has published information on eight more d...
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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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    Digital Health: ‘Connecting the Dots’ Across FDA Centers

    The US Food and Drug Administration’s (FDA) creation of a Digital Health Center of Excellence is in the works, although details offered Wednesday did not shed much light on when it’s coming or its envisioned role.   There are “lots of details to be ironed out,” said Bakul Patel, director for digital health at FDA’s Center for Devices and Radiological Health (CDRH), during a session on Wednesday at the AAMI/BSI/FDA International Conference on Medical Device Standards an...
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    Health Canada Encourages RWE Submissions

    In lock step with its US counterparts, Health Canada this week announced that it’s seeking to better use real-world evidence (RWE), while addressing certain specifics in protocol development and data quality concerns.  As real-world data (RWD) sources increase in quantity and quality, Health Canada explains how “prospectively planned clinical trials have been and continue to be considered the most robust tool for providing evidence of drug safety and efficacy,” although...
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    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...
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    Health Canada Opens Generic Drug Guidances for Consultation

    Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.   Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.   “The draft guidance documents have been releas...
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    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...