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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...
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    Advertising, Promotion, Labeling and the Role of Social Media in Regulatory Communications

    Articles throughout December explored advertising, promotion and labeling in addition to the role of social media in regulatory communications. Leading experts in the profession shared valuable insight on a wide range of issues impacting APL professionals today, including optimizing ad/promo regulatory affairs communications, Facebook chat study results and the use of hashtags, social media influencers and considerations, price transparency and assessing risk and strategic...
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    Regulatory Intelligence and Policy

    To support the release of the Q4 Regulatory Focus Article Series, Regulatory Intelligence and Policy: Shaping the Global Landscape , RAPS hosted a lively discussion on Regulatory Exchange with three regulatory intelligence experts, Meredith Brown-Tuttle, Matt Medlin and Kirsten Messmer. The experts , who were all authors in the series, offered their perspectives on the importance of regulatory intelligence and the integral role RI professionals play in defining strate...
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    The Brave new World of Social Media: Regulatory Perspective on Hashtags and Facebook Messenger

    This article discusses the emergence of social media for use in pharmaceutical advertising and promotion. The authors cover what “hashtags” mean, how they function, their uses and potential misuses and provide results of their investigation into how pharmaceutical companies using the social media platform “Facebook Messenger” respond to consumer questions received through social media. They conclude that the pharmaceutical industry and regulatory professionals should use s...
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    Assessing Risk and Strategic Business Decision-Making Without Consistent FDA Enforcement

    This article discusses how regulatory professionals can make benefit-risk decisions with limited Agency guidance materials or enforcement examples. The author concludes that with a scarcity of enforcement letters from FDA in recent years, regulatory professionals must turn to other tools to understand FDA and other government agency issues related to drug promotional activities.   Introduction   Over the past seven years, there has been a steady decline in the numb...
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    Global Pediatric Drug Development

    The article addresses global pediatric drug development and compares strategies and regulations in the US and the European Union (EU). The authors identify key regulations and resources to support pediatric drug development, describe some of the most important factors to consider when developing a global pediatric drug development strategy and point out some common “pitfalls” in the development of a global pediatric drug development strategy. This article is based on a pre...
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    Optimizing the Review Process of Advertising and Promotional Communications

    This article discusses how medical, legal and regulatory review committee members can best function to provide efficient and effective communication as well as a productive environment aimed at yielding creative, yet compliant, materials. The authors make suggestions for optimizing communications as part of the internal review process by providing clear understanding of regulations and establishing clearly defined processes to foster compliance. The authors also touch on t...
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    Clarity in Chaos: Best Practice Tips for Engaging Influencers for Pharmaceutical Promotion

    Engaging social media influencers for prescription drug promotion can present a challenge for most pharmaceutical companies; however, by working with the right social media influencer and operating within standing regulations, companies can reach appropriate patients via social media. This article demonstrates how one pharmaceutical company used social media to offer guidance to pharmaceutical companies considering using “media influencers” to promote their products. The a...