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    Transforming Regulatory Operations

    This article describes one global pharmaceutical company’s efforts to improve efficiencies, maintain compliance with new standards and gain greater internal alignment. By reorganizing its regulatory operations function, centralizing regulatory processes and implementing cloud-based technology to modernize regulatory information management, the authors describe the journey toward productive change.   Introduction: Making the Business Case for Change   Because the co...
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    Comparison of Data Requirements for the Approval of a Biosimilar Versus the Reference Medicine

    This article compares and contrasts several aspects of biological products versus biosimilar products. The author defines both biologics and biosimilars and explains how and why the two differ in terms of their organic natures. She also guides the reader through the biologic vs. biosimilar developmental and testing stages and through agency approval and postmarketing surveillance. The author clarifies important points to consider when developing biologic and biosimilar pro...
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    Curiosity: One of Life’s Most Valuable Commodities

    This article discusses the value in human curiosity for learning, living a more meaningful life and as an important tool for professional success. The author reviews several books on curiosity that outline why we are curious, explains different types of curiosity and suggests how we might not lose our curiosity as we age. Introduction While working for a medical device company, I frequently had the opportunity to interview new job candidates. One question I asked was...
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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 also must be fit-for-purpose to stimulate innovat...
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    Personalized Nutrition for Better Health: Targeting the Human Microbiome

    This article describes the strategic role of nutrition and the human microbiome in personalizing health and disease management and the need for diligent regulatory and policy action in light of the rapid pace of science and technology development and application of these fields. The authors cover the need for biomarkers for personalized targeting the micobiome, bringing innovations to the market, avoiding industry “hype,” creating the right regulatory framework for persona...
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    The Botanical Safety Consortium (BSC): The Development of a 21st Century Framework for Assessing the Safety of Botanical Dietary Supplements

    This article discusses steps to improve the safety of botanicals in dietary supplements. The authors discuss several US legislative initiatives and efforts by several nongovernmental organizations, such as the Council for Responsible Nutrition and the American Botanical Council, to track patterns of botanical use, and the Congress of the European Societies of Toxicology’s efforts to approach safety issues, including its establishment of the Botanical Safety Consortium and ...
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    Modernizing Canada’s Medical Nutrition Regulations for Food

    This article addresses the Canadian government’s opportunity to modernize its medical nutrition regulations for food and presents key learnings from the structure and implementation of several regulatory frameworks for Food for Special Medical Purposes (FSMP) globally. The author recommends an improved framework in Canada to better address the needs of patients and healthcare professionals.   Introduction   Malnutrition is defined as a deficiency, excess or imbalan...
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    Dietary Supplements and Public Safety: A Defense of DSHEA’s “Three-Legged Stool”

    This article discusses the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994 and its effects on the dietary supplement industry. The author addresses criticism of DSHEA and defends the intent and subsequent benefits of the legislation by identifying the “three legs of the stool” of the legislation—protection, safety and watchfulness.     Introduction   As the dietary supplement industry prepares to observe the 25th anniversary of the ...
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    Regulatory Challenges in Medical Foods: Natural Variations in Ingredients of Agricultural Origin

    This article examines the sources of variability in raw materials from “natural origins” and how Foods for Medical Purposes (FSMP) companies cope with and overcome the challenges posed by regulated nutrient levels. The authors examine the sources of this variability using the examples of one vitamin (B12) and one trace mineral (selenium) and consider how FSMP companies work with the challenge of narrow acceptance criteria set by the regulations. The authors propose that re...
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    Severe Acute Malnutrition (SAM): The Value of a Ready to use Therapeutic Food (RUTF) Guideline

    This article discusses the value of a Ready-to-use Therapeutic Food (RUTF) and the guidelines for its use. The author explains that because RUTFs are used in the treatment of children with Severe Acute Malnutrition (SAM) without medical complications, a guideline could help ensure products are safe, efficacious and of good quality. She concludes by noting how careful consideration of what should be included in the guideline, as well as provision for consultation with vario...
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    Update on the Regulatory Status of Cannabidiol in Food and Dietary Supplements and Future Prospects

    This article covers the regulatory status for using cannabidiol (CBD) as a dietary supplement and presents the US Food and Drug Administration’s (FDA’s) position as well as conflicting viewpoints taken by some in the industry. The impact of the Agricultural Improvement Act of 2018 (2018 Farm Bill) is evaluated along with the future prospects for CBD.   Introduction   Cannabidiol (CBD) is one of several cannabinoids found in the hemp and marijuana varieties o...
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    The Value of Engagement With Trade Associations in Policymaking, Regulation and Standardization

    This article presents an argument for the value that trade associations bring to healthcare in terms of promoting best practices, policies, regulations and standards. The author defines trade associations and lays out their functions and the value of those functions for regulators and policy makers and also presents defining characteristics of good regulations and good policies. The focus is on foods for special medical purposes and the author shares examples from the work...