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    Digesting FDA’s New Regulatory Definition of Dietary Fiber and its Impact on the US Food and Dietary Supplement Industry

    This article outlines the new regulatory definition of dietary fiber under the US Food and Drug Administration’s final rule for Nutrition and Supplement Facts labeling, including requirements for declaring ingredients as dietary fiber on the label outlined in the regulation. The author offers a timeline on FDA’s activities in the area of dietary fiber and discusses implications for the food and dietary supplement industry. FDA’s Final Rule on Nutrition and Supplement Lab...
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    Food Supplements in the European Union: the Difficult Route to Harmonization

    This article describes European Union food supplements legislation and discusses a number of “stumbling blocks” to full regulatory harmonization. The author reviews a number of EU-wide issues in food supplement legislation, including national versus EU agendas, the “grey zone” between food supplements and medicines, and the problems with food supplement “health claims.” In an effort to help companies be aware of what is coming so they can adjust their strategies according...
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    Four Gone, but not Forgotten

    This article discusses the lives and work of four important scientists who have passed on and who are in danger of passing out of the important annals of medical history if not appropriately remembered. The author frames this discussion with opinions about the importance of knowing about and giving credit to research “heroes” no longer with us as well as noting the importance of their discoveries and contributions, most of which created the foundations for today’s medical...
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    Master Protocol and Combination Products Development: A Step Closer to Precision Medicine

    This article discusses the challenges and benefits related to using the “master protocol” and “platform” study design in conducting clinical trials of combination products, trials where the product is comprised of two or more regulated components. The authors speculate on regulatory challenges arising from employing alternative clinical trial procedures and processes and examine changes in FDA policy regarding clinical trials with combination products. Introduction Comb...
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    Brazil’s Regulatory Environment Offers Positive Changes for Clinical Trials

    This article summarizes recent changes in regulations and submission processes in Brazil’s approach to conducting clinical trials that will speed the submissions processes and also help the country be more competitive in global clinical trials acquisition. The authors focus on changes affecting the main regulatory bodies involved in the review of clinical trials in Brazil—Agência Nacional de Vigilância Sanitária (ANVISA) and Comissão Nacional de Ética em Pesquisa (CONEP)....
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    Innovative Technologies, 3D Printing, Accelerated Pathways, Biosimilars and an Update on Brazil

    Articles posted throughout June featured various innovative technologies, including the increased use of artificial intelligence in the healthcare industry and the challenges of adopting 3D printing or additive manufacturing to develop products in the pharmaceutical industry. Other articles focused on the FDA’s Emerging Technology Program, critical technologies for conducting global clinical trials, complexities of global accelerated pathways in EU, US and Japan, innovati...
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    Trends in Biosimilars: Innovative Approaches to Expediting Development

    This article discusses innovative approaches to expediting biosimilar drug development. As sponsors of biosimilars seek additional efficiencies to get to the market more quickly, it behooves regulatory professionals to become aware of the different tactics and options that biosimilar drug developers can employ to bring copies of expensive biologics to the global market not only more quickly, but more broadly and less expensively. Introduction The biosimilars market cont...
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    Additive/3D Printing Manufacturing: Regulatory Concerns

    This article discusses “3D printing” or “additive manufacturing” for the manufacturing of medical devices, including replacement body parts. It draws much of its material from a new US FDA Guidance document that discusses the unique issues posed by this technology, key concerns due to radically different features of such manufacturing and various ways to address the resulting FDA quality and regulatory concerns relative to ultimate patient safety. Introduction The term ...
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    FDA Releases Novel Technical Framework for 3D Printed Medical Devices

    This article discusses the value, potential and challenges of using 3D printing (Additive Manufacturing (AM)) to develop products for use in the pharmaceutical industry. The author reviews the US Food and Drug Administration’s (FDA’s) guidance on AM in terms of design as well as manufacturing and device testing considerations. Emphasis is placed on the evolutionary aspects of providing final guidance on 3D printed products as well as the need for manufacturers using AM to...
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    Emerging Technology Integration in FDA’s Drug Approval Process

    This article discusses important aspects of the US Food and Drug Administration’s (FDA’s) “Emerging Technology Program” with a focus on emerging technology, such as continuous manufacturing and 3D printing, and details what information is to be included in drug submissions. The authors highlight a number of benefits of the program, including the synergy created between FDA and the pharmaceutical industry. Introduction An important step in FDA’s mission to support pharma...
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    Regulatory Challenges for Artificial Intelligence Applications in Healthcare

    This article addresses regulatory challenges associated with using artificial intelligence in healthcare. The authors explore challenges in regulating “digital health” and review various pathways to gain regulatory approval for artificial intelligence applications to be employed in healthcare. They recommend potential approaches for resolving regulatory challenges that may arise with the use of new technologies and discuss the variety of FDA initiatives aimed at helping t...
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    Unifying the Clinical Landscape to Drive Efficiency and Compliance

    This interview with Terry Murphy, Vice President of Janssen Research and Development, describes problems experienced with the company’s critical technologies for conducting global clinical trials, how the decision was made to replace them and what new technologies were implemented. Murphy reviews the benefits gained after the replacement was completed and also explains how the company maintains data security while they are “watching the marketplace and the evolution of te...