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  • Feature ArticlesFeature Articles

    Why Understanding Regulatory Affairs is Important to key Company Decision Makers

    This article discusses the reasons why continuous evaluation of the regulatory framework is important for company decision makers and how companies that make efforts to understand the regulatory landscape for their product benefit.   Introduction   The life science industry is one of the most heavily regulated industries. Executives, senior managers and investors must understand how different decisions about a product can impact its regulatory path and how this aff...
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    Economic Operators: Roles and Obligations Under EU’s MDR

    Regulatory and legal experts share their views on the European Union’s revised Medical Device Regulation ( MDR ) and the EU’s requirements for Economic Operators (EOs) to play major roles in medical device authorizations and postauthorization monitoring. The article also highlights roles and responsibilities for Manufacturers, Authorized Representatives, Importers and Distributors (MAID) for assuring compliance with new EU MDR in addition to public health/patient safet...
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    Changing Regulatory Landscape, Strategy and Global Policy

    January feature articles explored the vital role of regulatory within organizations and throughout the product lifecycle. Some of the leading experts in the profession have come together to share their valuable experience on a wide range of issues impacting regulatory professionals today, including regulatory leadership for a culture of quality, how to successfully hire and engage consultants, regulatory’s role in business strategies and UDI and recall management. Other ar...
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    Regulatory Affairs Consultants: Who Needs Them and Why

    This article discusses employing regulatory affairs consultants and offers advice on who needs consultants and why, the “dos and don’ts” of finding, managing and maintaining consultants, how to choose the right consultant with the right background and expertise for the needed tasks and consultant service and pricing models. This article was adapted from a RAPS Convergence presentation held in Philadelphia 21-24 September 2019.   Introduction   The advent of today’s...
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    [Updated] The Changing Regulatory Landscape for Insulin

    This article discusses the rising price of insulin and its historical context. The authors review and analyze legislative efforts to keep prices reasonable for patients and review the various barriers to making insulin less expensive. They conclude by looking at the potential effects of regulatory changes by FDA to transition insulin from regulation under the Federal Food, Drug and Cosmetic Act ( FD&C Act ) to the Public Health Service Act ( PHS Act ),* and suggest tha...
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    Drug Development Process for Biologics: Regulatory Expectations

    This article discusses various elements involved in “upstream” and “downstream” manufacturing processes for biologic drug development and the importance of their unification. The author elaborates on the complexity and sensitivities inherent in biologics and emphasizes safety considerations. Regulatory expectations for biologics development and approval are highlighted. This article relates specifically to the EU regulatory environment.   Introduction   The develop...
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    Regulatory Leadership for a Culture of Quality in the US Medical Device Industry

    This article discusses governance and implementation infrastructure as critical factors in cultivating a culture of quality and building the necessary trust employees may need to help achieve it. The author outlines the critical attributes of a culture of quality, explains how such a culture can be built, the benefits it offers and touches on the roles played by regulatory/quality professionals in leading the effort to build quality.   The Case for Quality   In 201...
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    How FDA Makes Decisions About REMS Requirements for Healthcare Providers

    This article discusses how companies can scrutinize regulatory precedent to best ensure healthcare providers fully understand risks associated with drugs and can safely administer them. The author covers FDA’s requirement that companies develop a Risk Evaluation and Mitigation Strategy (REMS), but highlights the lack of REMs specifics, especially where healthcare provider education and/or training is concerned. She concludes that companies should be proactive in determinin...
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    China’s Evolving Regulatory Environment: Special Report

    This article provides an overview of the clinical trial Investigational New Drug (IND) approvals and New Drug Application (NDA) approvals in China for locally developed and foreign-developed new drugs, based on information from the database and annual report of China’s regulatory authority, National Medical Products Administration (NMPA). The authors assess how the clinical trial market has responded over the past few years and analyzes the future of the China market. They...
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    Unique Device Identification and Recall Management: Starting with the Patient in Mind

    This article provides an overview of FDA’s medical device Unique Device Identification System Final Rule 1 and explains why including UDIs in health information and in device recalls can improve patient safety. The author offers an anecdotal case study of a patient suffering symptoms that could have been connected to her hip replacement had UDI information and its communication been as efficient as Vehicle Identification Numbers (VINs) in identifying automobile owners in ...
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    Applying FDA’s Rules in the new World of Online Marketing and Crowdfunding

    This article provides an overview of US Food and Drug Administration (FDA) authority, regulations and policies regarding promotion of medical devices through websites and social media. The principles discussed generally apply to promotion of pharmaceutical products also. The author discusses internet and social media marketing and online preapproval communications, specifically addressing “crowdfunding” and where FDA may focus its enforcement activity in this newer context...
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    How to Hire and Engage Consultants for Success

    In the regulated industry, consultants are engaged for a variety of activities ranging from manufacturing, to testing, to quality control and quality assurance, to regulatory affairs. This article discusses the types of reasons for which consultants are engaged and how companies can ensure success in executing the engagement. The author emphasizes points such as hiring the right consultant for a specific task, onboarding a consultant, clarifying and communicating expectati...