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    The Enforcement of Risk Evaluation and Mitigation Strategy (REMS)

    This article describes the evolution of Risk Evaluation and Mitigation Strategy (REMS) from a safety program to an enforcement tool. The potential pitfalls related to promotional activities are exacerbated by the statutory tools and public health implications associated with REMS. Companies should take heed of two cases that resulted in multi-million dollar payments and criminal charges for failing to follow FDA-imposed REMS requirements. Given the powerful resources avai...
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    The Changing Landscape of Drug Promotion in a Digital World and What it Means for Regulatory Reviewers

    This article discusses the changing landscape of drug promotion and what relevant technological communication changes, such as the Internet and social media, may mean for regulatory reviewers. The author focuses both on the healthcare professionals who are demanding quick and easy methods of getting the latest pharmaceutical product information via digital media and how pharmaceutical sales and marketing teams are addressing using the Internet and digital communication to...
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    Cybersecurity, Supply Chain Security, Good Distribution Practices and FDA’s Drug Registration Process

    Feature articles in December highlighted: cybersecurity regulations the benefits of serialization software EU GDP guideline five years later an overview of the current Israeli regulatory system conflicts with separate drug approval in adults and children components of FDA’s drug registration process how to perform a GMP audit the benefits of visual data Securing the Supply Chain Over the past decade, there has been an enormous explosion of minute networked m...
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    Integrated Quality Systems: An Overview of the Current Israeli Regulatory System

    This article discusses product quality, importation, manufacturing, storage and distribution of pharmaceuticals in Israel and the regulatory context for these topics. The author explains that while many international pharmaceutical companies operate in Israel and the regulation of pharmaceuticals in Israel is generally aligned with the European Union (EU) regulations, there are a number of differences between the two regulatory systems. Accordingly, this article provides ...
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    Cybersecurity Susceptibilities in Networked Medical Devices

    This article discusses how the US medical device industry is facing cybersecurity risks due to their wireless connectivity over the internet. It provides a brief overview of the common types of cyberthreats and the medical devices affected and describes the regulations in place to oversee this issue. Introduction Over the previous decade, there has been an enormous explosion of minute networked medical gadgets supporting an assortment of health maladies, right from the ...
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    Vision and Visibility: Converting Compliance into Competitive Advantage

      This article outlines how serialization software can unlock additional value beyond regulatory compliance for both patients and those in the pharmaceutical industry and discusses how using track and trace functions also provide protection against counterfeit, stolen or contaminated drugs. The author explains how forward-thinking organizations are using serialization software to enhance operational efficiency, partner engagement and stronger patient-centered care. Intr...
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    Integrated Pharmaceutical Supply Chain Security Through Serialization and Authentication

    This article discusses the complementary role of authentication in serialization programs. It is the first article in a series designed to give regulatory professionals and other managers in the pharmaceutical industry an understanding of government mandates for product serialization and to highlight certain key related issues. Other planned topics in the series are briefly described, including an introduction to the enhancements that blockchain technology may bring to se...
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    Visualizing Data

    This article discusses the history of making data visual and suggest ways to keep viewers of visual data engaged. The author offers thoughts on software programs and books that may serve as good sources for learning more about visual data presentation. Introduction As part of management review, teaching, panel meetings, budgets or during an inspection by notified bodies or regulatory agencies, regulatory affairs personnel are frequently called upon to provide data to di...
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    Safety First

    This article reviews the development of global Good Distribution Practices (GDPs) against the background of an increasingly complex pharmaceutical supply chain, five years after the initial implementation of the extended EU GDP Guideline. Introduction On 5 November 2018, the current EU GDP Guideline turned five years old. 1 What have we learned in those five years? Have we succeeded in achieving a better protection of the integrity of pharmaceutical products and for...
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    Separate Drug Approval in Children is not Based on Science

    This article discusses the flaws and historical roots of separate drug approval in adults and children, caused by exaggerated warnings of drug toxicities, which are appropriate for newborns, but not for all minors until they become adult. Hidden conflicts of interest include the American Academy of Pediatrics‘ (AAPs‘) desire for pediatric research funds, the regulatory authorities‘ vision for on-label pediatric drug prescriptions only and industry's desire for patent exte...
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    Performing a GMP Audit

    This article discusses the first-time experience of performing an audit from a regulatory professional’s perspective and is directed toward those who may never have participated in an audit. The author explains why audits should be conducted, summarizes key aspects of performing an audit and explains how findings might provide insight into the “bigger picture” of how hands-on manufacturing and good manufacturing practices are conducted in addition to being incorporated in...
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    FDA’s Drug Establishment Registration Process

    This article describes the detailed processes for firms manufacturing, preparing, propagating, compounding or processing drugs in the US or offering drugs for import to register with the US Food and Drug Administration (FDA). The author covers vital components of the registration process, including information on a firm’s DUNS Number, the Establishment Registration Structured Process Labeling (SPL) document, submitting the SPL and updating or changing an FDA registration....