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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...
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    The Critical Role of Thickeners in the Therapeutic Medical Management of People with Dysphagia

    This article discusses the value of thickeners for patients suffering from “dysphagia,” a term used to describe difficulty in swallowing. The author covers the health risks of untreated dysphagia, particularly for geriatric populations, thickening agents for food and drinks, levels of thickness, the economic consequences of untreated dysphagia, prescriptions for treating dysphagia and supervision by qualified healthcare professionals and regulatory considerations from an E...
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    Cybersecurity, Regulatory Intelligence, Software as a Medical Device and Data Integrity Failures

    Feature articles throughout May examined global regulatory compliance and enforcement issues, including FDA’s review framework for medical devices, global cybersecurity compliance and a process for communicating with China's Center of Drug Evaluation (CDE) during drug development. Other articles explored Regenerative Medicine Advanced Therapy (RMAT) designations, changes in guidance documents, new legislation and helpful regulatory intelligence tools. Experts also provided...
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    Regulatory Strategist Toolbox: 2018 FDA Regulatory Intelligence Briefing

    If you thought 2017 had a lot of changes, 2018 was even busier (and 2019 seems to be shaping up just the same if not busier). This article explores the major changes during 2018 including guidance documents drafted and finalized, new legislation, other areas of interest and some tools to help you explore additional areas.   Strategic Policy Areas (Drug/Biologic Specific Only) Summary   The following four priority areas were identified in FDA’s 2018 Strategic Polic...
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    Regulating Software as a Medical Device in the age of Artificial Intelligence

    This article summarizes the current and proposed regulatory landscape for software as a medical device (SaMD) with artificial intelligence and machine learning capabilities. The author provides definitions for SaMD, categorization and testing features and how to approach and adjust regulatory pathways for SaMDs that “learn” by using real-world evidence to continuously adapt and improve and, therefore, may need to be re-submitted for a new premarket approval due to changes ...
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    Investigating Data Integrity Failures for Manufacturing Changes: Human Factors

    This article discusses the importance of considering human factors when investigating data integrity failures. The author reviews the potential for human factors to cause data integrity failures, describes how people can discover solutions for preventing data integrity failures and recommends ways to reduce failures.   Introduction   More than 90% of data integrity failures are considered to be unintentional with no apparent efforts to violate or falsify data. Ho...
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    Protecting the Healthcare Infrastructure: Global Cybersecurity Compliance

    This article reviews past and current efforts to protect medical devices and other connected healthcare infrastructure from security breaches. The authors cover recent regulatory efforts in Australia, Canada, China, Europe, Japan and the US aimed at enhancing cybersecurity and industry’s efforts in cybersecurity regulatory compliance to protect patients as well as healthcare infrastructure.   Introduction   What are the Issues?   The US healthcare and public ...
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    Will the FDA Precertification Pilot Program Work?

    This article discusses the new pilot program from FDA that aims to make it easier for qualified companies to move software through premarket review, while better leveraging postmarket data collection, and whether the program will work in practice as planned.   Introduction   Digital health products often fall into a class of their own. With the tsunami of Software as a Medical Device (SaMD) products soon to go through the approval process, FDA is proactively lookin...
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    Global Medical Device Cybersecurity Compliance Requirements

    This article discusses compliance requirements to maintain global medical device cybersecurity. The author provides examples of recent cybersecurity breaches and also reviews efforts made by regulatory agencies in the US, Australia and China to be proactive in encouraging better cybersecurity, offering tools and tips to help a variety of healthcare organizations to achieve better cybersecurity.   Introduction   Cybersecurity can be defined as a process for preventi...
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    Communication With the Chinese Center of Drug Evaluation (CDE) During Drug Development

    This article provides an English translation of the Chinese Center for Drug Evaluation’s (CDE’s) regulations for communication with CDE on meeting management practices. The author describes standard procedures for requesting, preparing for, scheduling, conducting, rescheduling/cancelling and documenting meetings or other correspondence with the agency.   Introduction   In October 2018, China’s national drug regulatory body, the National Medical Products Administrat...