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    Orphan Drug Regulations in Europe

    This article defines orphan drugs and provides an overview of the evolution of European orphan drug regulations. Incentives are addressed including orphan drug legislation and policy, the criteria for orphan status designation and the authorization process for gaining an orphan drug designation in EU. Introduction “Patients suffering from rare conditions should be entitled to the same quality of treatment as other patients.” This sentiment provides the basis in European...
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    How FDA is Using REMS to Help Manage the Opioid Crisis

    This article discusses how FDA has been using the Risk Evaluation and Mitigation Strategies (REMS) program to try to limit opioid misuse and abuse by restricting the availability of these important drugs to patients who really need them to treat intractable pain. For several opioids, FDA has urged manufacturers to work together to create shared REMS to expedite management and assessment of the REMS requirements. Introduction During the first decades of the 21st century,...
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    Complying With the new EU IVDR

    This article discusses processes and plans that need to be developed by In Vitro Diagnostic (IVD) companies to address the new EU In Vitro Diagnostic Regulations (IVDRs) in advance of their coming into full force in 2022. Issues discussed include the differences between IVD and IVDR, new IVD classifications, notified bodies, new clinical evidence requirements and when to begin transitioning to the new requirements. Introduction On 5 May 2017, the In Vitro Diagnostic Re...
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    Navigating the Development of Pediatric Plans

    This article details a practical overview of the information that should be included within a pediatric plan, focusing on EU regulations with a comparison to the legislation issued by FDA. The author examines the common mistakes and misunderstandings that can occur when submitting such documents. Introduction For all new medicines seeking Marketing Authorization (MA) in the EU and US, pediatric plans must be submitted, with exceptions in some instance, i.e., FDA recogni...
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    Drug Delivery Combinations and new EU Medical Device Regulations

    This article discusses regulatory issues related to Drug Device Combinations (DDCs) and speculates on how they will continue to be regulated as medicines under the new EU Medical Device Regulations. The authors raise numerous questions regarding the respective scopes of the notified body and competent authority (e.g., EMA) with regard to DDCs and how they might cooperate and offer suggestions regarding considerations and changes that may need implementation under the new ...
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    An Update on Orphan Drugs in Canada

    This article discusses Health Canada’s current approach to orphan drugs for rare diseases and how initiatives to improve regulatory review may impact orphan drug registration in Canada. History Canada does not have a specific regulatory framework for orphan drugs. In October 2012, Health Canada announced two initiatives to encourage the development and availability of orphan drugs in Canada. The first was to create a new approach for the authorization of orphan drugs an...
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    Salt: Needed, Widely Used, Often Misunderstood

    This article discusses dietary salt needs, the history of salt use and why its use should be studied to further investigate links to cardiovascular disease. The author cites a potential study on salt intake aimed at determining the unhealthy consequences of high salt intake and closes by reviewing recent studies suggesting that too much salt in the diet can lead to a variety of cardiovascular problems, including high blood pressure and the potential for heart attack or st...
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    Overcoming the Challenges in Getting Cancer Vaccines to Market

    This article discusses advances in the development of “personalized” cancer vaccines and reviews the many challenges that need to be overcome to get new cancer vaccines approved and on the market. The authors highlight FDA’s “Regenerative Medicine Advanced Therapy” (RMAT), a comprehensive policy framework aimed at providing oversight for cancer vaccines and regenerative medicine products, including novel cellular therapies. Introduction Cancer continues to be one of the...
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    Nutrition in Health and Disease Management

    Over time, regulatory frameworks have evolved to protect consumers and patients. An unprecedented progression of demographics—including an aging society, noncommunicable chronic diseases, and transforming innovations in healthcare—pose challenges and provide potential opportunities. Action is needed to develop timely, appropriate and affordable healthcare solutions for patients and society. Policies and regulatory frameworks must also be fit-for-purpose to stimulate innov...
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    CGMP Requirements for Companies Using Contract Manufacturers

    This article discusses current Good Manufacturing Practice (CGMP) requirements for companies making dietary supplements and who use contract manufacturers. The author highlights FDA comments on this issue, presents several court cases determining who is responsible for CGMP compliance and explains four important areas of CGMP concern for companies utilizing contract manufacturers. The author also offers ways to stay in compliance, such as auditing the contract manufacture...
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    Update on the Amarin-ITC Case and the Issues at Stake

    This article discusses the history and implications of a lawsuit claiming that certain omega-3 fish oil products, synthetically-produced, were unlawfully labeled and marketed as “dietary supplements. The parties involved include a pharmaceutical company in Ireland, the US International Trade Commission, the US Food and Drug Administration and the US Congress. The outcome of the case could have implications beyond concentrated omega-3 products and the supplement industry a...
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    Evaluating Science for Health Claims: An Evolving Landscape

    The FDA’s current guidance on evidence-based review for the science needed to support food and dietary supplement health claims was published in 2009. Although this guidance has not changed in the past decade, as demonstrated by two recent agency decisions regarding health claims, the agency’s interpretation of the guidance appears to be changing. The article reviews these two cases—revocation of the soy protein and coronary heart disease health claim and the conclusion t...