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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...
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    Regulatory Requirements for Meal Replacement Products: An International Review

    This article reviews and discusses the regulatory status of meal replacement products internationally with an emphasis on 1991 Codex Alimentarius Commission (CODEX), relevant product categories, intended purposes and consumer confidence. Restructuring some of the regulations in the US may be useful to both manufacturers and consumers. Introduction “Meal replacement” is a term used in the US and other parts of the world to describe a type of product used to replace a per...
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    Opportunities and Challenges in New Nutritional Products Innovation

    This article reviews the legal and regulatory definitions of medical food with emphasis on the Distinctive Nutritional Requirements (DNR) imposed by a disease that differs from the requirements for the normal healthy population. The author addresses clarifying the term DNR, identifying and validating more sensitive biomarkers to help explain variability in individual nutrient needs and encourages dialogue among nutritional scientists and researchers in public and private ...
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    Impact of Changing Scientific Recommendations on Nutrition Policies

    This article reviews the evolution of nutrition recommendations and how they are reflected in current policy decisions. A special focus is placed on fat and carbohydrate recommendations and their associated risks for non-communicable diseases. Introduction In the first half of the twentieth century, the primary focus in nutrition was on the prevention of undernutrition through adequate intake of micronutrients, energy and protein. However, by the second half of the cent...