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    Regulatory Labeling: Preparing for Launch

    This article discusses US labeling activities for drugs and biologics from postsubmission of a New Drug Application (NDA), Biologics License Application (BLA) or supplemental NDAs/BLA to approval. The author recommends useful FDA manuals and information as guides and covers labeling comments from FDA, team planning procedures, assigning team roles, responsibilities and timelines, negotiation processes and final approval.   Introduction   Pivotal studies have been c...
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    Impact of Innovative Healthcare Technologies: Regulatory Concerns of Ambulatory Cardiac Monitoring Devices

    This article provides an insight into the various types of Cardiac Monitoring Devices (CMD) available and their usefulness in remote cardiac monitoring for the early detection and treatment of arrhythmias. The article focuses on the technological innovations incorporated into these devices and the impact of this technology on the healthcare industry, regulatory challenges associated with their clinical utilization and potential solutions to those challenges.   Introduct...
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    Regulatory Intelligence Communication for Business Impact

    This article focuses on maximizing Regulatory Intelligence (RI) in response to specific stakeholder requests and offers best practices recommendations for RI communication. The authors provide an overview of information delivery methods and their applicability and present general considerations for communicating RI information by spreadsheets, text documents, slide presentations, strategy reports and competitive intelligence reports. They also highlight the use of due dili...
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    The Emerging Role of Artificial Intelligence in Healthcare

    This article discusses current and future Artificial Intelligence (AI) applications in healthcare and examines AI’s potential for adding efficiency to pharmaceutical research and medical practice as well as AI potentially providing better healthcare and patient outcomes, especially in terms of diagnostics and treatment. The author presents ethical concerns of AI applications, the potential for AI misuse and the case for developing ethical standards.   Introduction   ...
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    Risk Management Comes of Age. Have we?

    The first edition of the 2019 Regulatory Focus Article Series provides a much-needed comprehensive update on the emerging and evolving field of therapeutic risk management; and while bearing the title of ‘principles,’ this collection of articles also provides a long overdue review of many of the practices which have devolved from those principles.   What does it mean for a field to come of age?   Coming of age is a wonderful cultural concept, translated into col...
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    FDA’s Oncology Clinical Trial Makeover

    Recent communication by FDA affirming its support for modernized oncology clinical trial conduct, manifested in four guidance documents addressing adolescents, conduct of First-in-Human (FIH) expansion cohorts, the use of placebo/maintenance of the study blind and master protocols. This article provides an overview of new FDA guidances related to oncology drug development and a review of pilot programs aiding faster access to new, innovative treatments without increasing r...
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    New Regulations Imposed on Overseas Inspections of Drugs and Medical Devices

    This article discusses the most recent regulations imposed by China’s National Medical Products Administration (NMPA) on foreign manufacturers regarding China’s inspections of drugs and medical devices. The author covers inspection details from four chapters in the new regulation, all pertaining to general provisions, inspection planning, conducting an inspection, the inspection report and inspection outcomes. The author discusses an Annex to the regulation covering inspec...
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    Regulatory Intelligence, Risk Management and Drug Promotion

    Feature articles over the past weeks covered strategies for regulatory intelligence communication and management, the need for quality, relevant and timely intelligence and the importance of regulatory intelligence when preparing for meetings with FDA and other global regulators. Articles also covered emerging trends in risk management, risk evaluation and mitigation strategy and the changing landscape of drug promotion. Regulatory Intelligence   To stay current wit...
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    Emerging Trends in Risk Management for Pediatric Patients

    This article describes recent additions to the EMA’s pediatric risk management toolbox, explores the pragmatic implications of these developments for industry and concludes with a discussion of the future evolution of risk management in supporting the safe and appropriate use of medicinal products in children.   Introduction   The past decade has witnessed a major advance in the availability of medicinal products for pediatric patients. 1 A pivotal turning point i...
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    Postmarket Surveillance in a Digital Health Solution World: Challenges and Opportunities for an Evolving Industry

    This article discusses the challenges and opportunities within the digital health technology postmarketing safety and surveillance arena faced by many manufactures. The authors discuss the opportunities and challenges these devices and technologies may present, compared to the traditional healthcare products in the regulated arena.   Introduction   The term digital health solution is used to categorize technology available through a multitude of devices which provi...
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    Managing Regulatory Intelligence for Medical Devices

    This article discusses how medical device guidance documents, regulations, standards and requirements are presented in increasing amounts and how regulatory professionals can access, assess, manage and ultimately report to their organizations on the potential impact of regulatory changes. The author covers where and how to access documents and methods for keeping up with regulatory changes using searchable databases, such as provided by FDA, as well as how to find informat...
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    FDA Meetings: The Application of Regulatory Intelligence in Preparation and Execution

    This article illustrates how to best leverage a dedicated Regulatory Intelligence (RI) function or skill set to prepare for and have the most successful regulatory interaction with FDA. It provides insight and suggestions regarding the role RI professionals can play to help assure a successful interaction during each FDA meeting phase.   Introduction   Regulatory Intelligence (RI), in one form or another, has always been a component in a successful FDA meeting. How...