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    New method to an old approach: A semiquantitative approach for determining probability of regulatory success for ASEAN markets

    An objective assessment guide for estimating the likelihood of obtaining regulatory approval for marketing authorization applications submitted to local regulatory agencies is critical to facilitate commercial launch planning. In this paper, we describe a harmonized guide designed to estimate the probability of regulatory success (PRS) in the Association of Southeast Asian Nations (ASEAN). This guide focuses on a standardized set of criteria for semiquantitative assessment...
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    From real-world data to real-world evidence: An interregional perspective

    In recent years, data generation in clinical practice outside clinical trials has grown exponentially, largely because of an increase in the number of advanced signal detection technologies, including sensors, imaging, measurements, and mobile devices. At the same time, database capabilities have also expanded because of advances in storage technology. As a result of the innovative digitalization of the collection of real-world data (RWD) together with artificial intellige...
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    Considerations for regulatory application of RWD-generated external comparators

    Properly designed and analyzed external comparators (ECs) built from real-world data (RWD) and the resulting real-world evidence (RWE) can be compared in certain situations with data generated from single-arm or traditional randomized clinical trials to support regulatory decisions. Proper development, design, and use of ECs requires more than simple matching of the clinical trial inclusion and exclusion criteria within the RWD source. A focus on the specificity of the res...
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    Regulatory considerations for real-world research studies in Europe

    Real-world research studies are a valuable source of real-world evidence (RWE). In Europe, successful deployment of these studies is dependent on identifying, understanding, and demonstrating which regulations are not applicable, as well as identifying (and complying with) the regional (Europe Union) and national requirements that are applicable.   Introduction The European Medicines Agency (EMA) recently called for high-quality observational research of real-world...
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    RWD, RWE, and improved patient outcomes: From FDA's Mini-Sentinel to real-world examples

    Uses of real-world data and evidence (RWD and RWE) have proliferated in recent years, driven by advances in data-gathering tools and methods and enhanced understanding of the value of such data and evidence. Under the 21st Century Cures Act of 2016, Congress codified RWD and RWE in the drug development and approval process. There are many opportunities for the use of RWD and RWE in the approval, labeling, clinical use, and marketing of medical products to enhance individu...
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    June’s Regulatory Focus: Nutrition in health and disease management, and the gut microbiome

    This issue marks the 6th annual RAPS series on nutrition in health and disease management, and the gut microbiome, in which global experts write about food, nutrition, and dietary supplements from regulatory, trade, marketing, and legal perspectives. In keeping with the series, articles in the current issue examine US Food and Drug Administration (FDA) regulatory guidance and requirements, especially regarding dietary supplements, bioengineered products, probiotics, and CO...
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    Global regulatory trends in CBD use in food and food supplements

    This article examines the regulatory trends for using cannabidiol (CBD) as an ingredient in foods and food supplements and provides guidance for companies to interpret current regulation and predict its future direction. The author discusses navigating current regulatory complexity to realize commercial opportunities and outlines the challenges and opportunities for bringing food and food supplement products containing CBD to markets around the world.   Introduction ...
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    ‘Immune’ claims and COVID-19

    Products such as elderberry, echinacea, and vitamin C have long been marketed for added support for the immune system. Although regulators have occasionally targeted claims for preventing or treating colds, flu, or other diseases, marketing products with “immune support” claims has generally proven to be a safe harbor for companies. As long as products include one or more ingredients with valid in vitro or other efficacy evidence, “immune support” claims have tended to be ...
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    Disclosure under the national BE standard for dietary supplements

    With the approach of the 1 January 2022 mandatory compliance deadline for the National Bioengineered Food Disclosure Standard (BE standard), manufacturers and importers of dietary supplements should work to develop strategies for compliance and evaluating each product’s bioengineered (BE) status if they have not already done so. This article reviews the requirements for disclosure under the BE standard.   Introduction In May 2014, the Vermont legislature passed an a...
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    The ASEAN harmonization of technical standards on health supplements – An industry perspective

    Many countries in the Association of Southeast Asian Nations (ASEAN) require registration of health supplements, which generally takes a few months to years. There have been many different interpretations of the principle-based standards or regulations among the ASEAN member nations, making right-first-time regulatory submissions for the region hard to achieve and, absent defined review limits (such as rounds of questions/letters of deficiencies), lead times for approvals ...
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    Current status and future FDA enforcement of dietary supplements

    FDA observations for adulterated dietary supplements have remained consistent since 2010, even during 2020, when inspections were down 47% and accommodations for compliance were made because of the COVID-19 pandemic. These include requirements to establishment specifications, testing to determine if specifications are met, use of master manufacturing records, preparation of batch production records, and ensuring quality responsibilities are defined. The pandemic has also r...
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    Enhancing consumer confidence and supplement access through harmonized retail standards

    Although third-party audit, certification, and retail standard programs highlight reputable companies and help ensure that dietary supplements on store shelves are safe and unadulterated, multiple standards create a complicated patchwork of requirements that are difficult for manufacturers and consumers to navigate. Responsible industry has emphasized the need to harmonize standards by eliminating duplicative, costly testing and allowing retailers to confirm a manufacturer...