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    China’s digital health regulatory framework for SaMD

    There is no specific definition in the People’s Republic of China regulatory framework clarifying the term “digital health,” but there is general acceptance that the term refers to digital technologies applied across the healthcare sector. 1,2 This article describes recent updates to the regulatory framework for digital health applications that qualify as medical devices under China’s regulations.   Keywords – China, digital health, regulatory   Introduction...
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    Prompted by recent recalls, regulators scramble to address novel nitrosamines

    Updated 3 November 2022* The discovery of novel nitrosamine impurities in pharmaceuticals, coming after the valsartan/nitrosamine crisis of 2018, has caught global regulators and industry by surprise as more products than anticipated are affected by these impurities.   The situation raises new questions about how to set daily acceptable intake limits for pharmaceutical products when toxicological data on these impurities is scarce.   These novel nitrosamines, ...
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    Remote regulatory assessments: Pharma, device groups want more details on FDA guidance

    Trade groups representing the pharmaceutical and medical device industries, while largely supporting the use of remote regulatory assessments (RRAs) as outlined in the US Food and Drug Administration’s (FDA)’s recent draft guidance, questioned how these assessments would work in practice, including how they would be coordinated with onsite inspections, whether they can be leveraged by foreign regulators and how FDA plans to ensure the privacy of companies and personnel tha...
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    Personalized nutrition

    Personalized nutrition is founded in evidence-based science and draws on individual-specific information to help consumers promote positive, sustainable dietary behavioral change resulting in measurable benefits in health improvement and maintenance, or disease-specific benefits. This article provides a comprehensive definition of personalized nutrition and examines its regulation globally and in the EU in regard to data protection, product qualification, and claims.   ...
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    Managing regulation of mental health-related claims in the COVID-19 era

    As we enter the third year of the COVID-19 pandemic, consumers are increasingly turning to dietary supplements to help them manage the daily stress of this unprecedented time. However, as demand for dietary supplements associated with stress and anxiety-reduction has increased, so has regulatory scrutiny from the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC). This article provides an overview of the FDA and FTC’s regulations and enforcement activ...
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    Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...
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    FDA officials aim to stop misuse of the term ‘digital biomarker’

    While a lot of researchers claim they are capturing digital biomarker data, they may in fact be collecting clinical outcomes assessment (COA) data according to some US regulators. To clarify the differences, top US Food and Drug Administration (FDA) officials have defined digital biomarkers versus other kinds of data in a new article.   According to FDA officials in an article published on 25 March in npj Digital Medicine , a digital biomarker is “a characteristic o...
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    Stakeholders want more clarity about devices used for remote clinical studies

    A number of stakeholders have written to the US Food and Drug Administration about the agency’s recent draft guidance on how digital health technologies (DHT) could be used to conduct clinical trials remotely. Some have concerns about the agency too narrowly defining what products can be used for remote monitoring, while others argue it’s not broad enough. Some are also asking the agency to include smart packaging in the guidance.   In December, the agency published i...
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    FDA issues draft guidance on assessing physiologic closed-loop control devices

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) in late December issued a draft guidance on developing medical devices with physiologic closed-loop control (PCLC) technology to ensure their safe and effective use. Submissions should carefully weigh patient and device-related risks as well as use-related hazards.   These devices consist of a sensor that measures a physiologic variable from the patient, a controller/control...
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    Digital health tech in clinical investigations: FDA issues draft guidance

    The US Food and Drug Administration, as part of an end-of-year spate of guidance documents, has issued a draft guidance for sponsors who wish to use digital tech to aid in remote clinical data acquisition.   Digital health technologies (DHTs) stand to benefit clinical investigations in a multitude of ways, but regulatory considerations have to be weighed as the technologies are employed, noted the agency in setting out the background for the draft guidance, issued in l...
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    ICH releases revised Q9 guideline to improve risk assessments

    The International Council for Harmonization (ICH) issued a revision of the Q9 guideline that aims to address the shortcomings of the current guideline. The goal of the revision is to provide “more scientific and robust applications of quality risk management principles (QRM)” leading to “fewer quality defects and recalls” and reduced costs for the pharmaceutical industry, according to an ICH business plan .   The ICH Q9(R1) guideline was published on the European Me...
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    Improving transparency of regulatory data at EMA, Health Canada, FDA

    Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada (HC) have gotten better at disclosing previously confidential clinical data, a study published in The Journal of Law, Medicine & Ethics has found.     However, each agency discloses this data in a variety of different ways, according to Alexander C. Egilman, with the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital in New Haven, CT,...