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    Supply chain disruptions: FDA guidance and temporary policies

    The COVID-19 pandemic caused one of the most prominent displays of supply chain disruption in the modern era. However, the US Food and Drug Administration (FDA) found ways to allow for regulatory flexibility by issuing guidance documents while still managing to protect consumers from adulterated and misbranded food.   Keywords – COVID-19 , FDA, food, guidance, pandemic, supply chain   Introduction The complexity of modern supply chains is never more eviden...
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    Proposed updates hint at dietary supplement legislative reform

    The dietary supplement industry has grown in the 28 years since the passage of the Dietary Supplement Health and Education Act (DSHEA), but the legislative reform has not been commensurate with those industry changes. This article discusses six key legislative updates proposed by FDA, industry, and consumer groups, suggesting reform is on the horizon for DSHEA.   Keywords – dietary supplement, Dietary Supplement Health and Education Act, DSHEA, CBD, hemp, listing, ...
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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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    An update of China’s food safety regulatory framework

    This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Introduction Since the melamine crisis in 2008, the overall food safety situation in China has been improved significantly. The first Food Safety Law w...
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    FDA ‘high-risk’ foreign inspections: Post‒COVID-19 response to GMP challenges

    This article examines the US Food and Drug Administration’s (FDA) return to inspections that were put on hold during the ongoing COVID-19 pandemic. It outlines the agency’s oversight of drug and biological products during the pandemic and its plans moving forward. The authors summarize the agency’s guidance and policies, industry considerations, and recommendations to manufacturers preparing for their next FDA inspection.   Keywords FDA, inspections, quality, risk m...
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    Five reasons to invest in a dedicated regulatory intelligence department

    This article presents some key points for consideration regarding the establishment of a dedicated and centralized regulatory intelligence department.   Keywords – centralized, dedicated department, regulatory intelligence   Introduction Regulatory intelligence has become an increasingly important component of regulatory affairs as the global landscape expands and changes, and professionals and businesses must adapt rapidly to remain current and viable. I...
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    FDA guidances for medical device regulation after enforcement discretion and EUA expiration

    This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires. These policies may evolve as the US Food and Drug Administration (FDA) awaits declaration from the secretary of Health and Human Services (HHS) stating that the pandemic has ended. The author suggests this limited oversight of the manufacture of ...
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    April’s Regulatory Focus: Specialist vs. generalist, RI, and more

    Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an in-house regulatory database in the oncology setting, and strategic planning. Also included are articles on expedited regulatory pathway options, selecting control groups in pediatric clinical trials, and the role of artificial intelligence...
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    Regulatory specialist, generalist, or generalized specialist: Weighing the options

    This article explores the role of a generalist and a specialist within the regulatory profession, as well as considerations in today's evolving regulatory landscape. To decide on the best path forward, it is important to understand current global market expectations from the regulatory profession, as well as compensation depending on job level and education in the healthcare sector.   Keywords – generalist, generalized specialist, professional development, skill set...
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    Managing the challenges of the new IVDR: Lessons from the pandemic

    This article details how regulatory intelligence can help medtech companies assess the impact of the new EU legislative framework for in vitro diagnostics (IVDs). Using the example of COVID-19 antigen tests, the author looks at how regulatory intelligence helped device manufacturers manage the changes in regulations during the pandemic and how the lessons learned can support the industry in assessing and planning for the impact of the new legislative framework for IVDs tha...
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    Strategic applications of regulatory intelligence

    Organizations require regulatory intelligence (RI) solutions now more than ever, especially in the current context of rapidly emerging technologies and evolving regulatory landscape. This article provides an overview of a three-part process of RI, consisting of data input, analysis, and output, and its strategic application in the product life cycle and business processes in achieving a competitive edge. RI has a significant range of applications and could be a practical ...
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    In-house regulatory database development: Solution for a competitive oncology landscape

    The unprecedented number of new investigational agents in clinical development in the competitive oncology space presents a significant challenge for regulatory intelligence professionals. Strategic decisions are complicated by the overwhelming amount of regulatory information scattered across numerous repositories. The development of an in-house database may facilitate success for businesses in the prevailing information-centric world. Effective implementation of an in-ho...