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    New Drug Price Transparency Requirements in Direct-to-Consumer Advertisements

    This article discusses the potential impact of an amendment to a US Senate healthcare spending bill that could require drug manufacturers to disclose their drug prices in all direct-to-consumer television advertisements. The author questions whether creating this kind of transparency will help lower drugs costs, as some claim it will, or if passed, confuse consumers and negatively impact the pharmaceutical industry and how regulatory professionals do their jobs. Introduc...
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    Global IVD Regulations: Are they harmonized yet?

    This article will examine the In Vitro Diagnostic (IVD) medical device regulations in multiple regions to provide an assessment of whether or not harmonization efforts have been fulfilled. Millions of healthcare professionals and patients around the globe rely on in vitro diagnostic medical devices every year to provide accurate results and be safe to use. In a global economy, manufacturers want to get their products on the market in multiple regions as expeditiously as p...
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    LDT Regulation: Past, Present and Future

    This article summarizes the regulatory history of Laboratory Developed Tests (LDTs) and describes where we are now and where we may be heading. Introduction George HW Bush was president when the Food and Drug Administration (FDA) first floated the idea that it could regulate Laboratory Developed Tests (LDTs). Four presidents later, the issue of how FDA should regulate LDTs—if at all—remains controversial and unresolved. The intervening 26 years, though, have hardly bee...
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    A Comparative Study of US and EU Medical Device Regulations

    This article presents a comparative study of medical device regulation between US and EU. Millions of patients worldwide depend on broadening the array of medical devices for the diagnosis and management of their disease. A frequent point of comparison for device regulation in the US is regulation in the EU. Arguments persist about the differences in US and EU regulatory approaches, costs and the length of time for medical device clearance or approval, marketing and postm...
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    Theoretical Perspective of Technology for Regulatory Science: Part 2

    Regulatory science is the discipline that oversees, creates and implements innovation for global health needs. Yet, no philosophy of technology exists for regulatory science. This article attempts to fill that gap and focuses on problem-solving tools or 'global skills'. Introduction Part one introduced the concept of a regulatory science philosophy of technology. 1 Figure 1 depicts a regulatory science key representing the means to unlock new drug and device outcome...
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    What are biosimilars and why are they important?

    This article provides an overview of biosimilars and explains their benefits, similarities to “reference” biologics, clinical applications and recent regulatory challenges. It is intended to provide a top-level introduction to regulatory professionals who have a limited awareness of or are new to biosimilars. Introduction Biosimilar medicines are no novelty, they have been around for more than a decade. The first biosimilar approved in Europe was Sandoz’s somatotropin b...
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    Regulatory Progress of Biosimilars: An Update

    This article discusses issues related to the development and marketing of biosimilars aimed at having the same therapeutic effects as biotherapeutics. The author covers biosimilar approvals in Europe and the US, comparability studies, labeling issues, interchangeability and postmarketing issues. Over the last 10 years, biosimilar acceptance has progressed significantly both in the EU and US, although the author notes several organizations advocating for more complete, acc...
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    Advertising, Promotion and Labeling, Accelerated Approval and Regulatory Science

    October feature articles covered the following topics: the changing advertising and promotion landscape labeling accelerated approval regulations for drugs and devices comparability bridging studies for combination products FDA resources regulatory science In January 2017, the release of two guidance documents shook the pharmaceutical advertising and promotional landscape and, consequently, affected the “risk tolerance” level of regulatory professionals. In “ The...
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    Theoretical Perspectives of Technology for Regulatory Science: Part 1

    Regulatory science is the discipline of overseeing, creating and implementing innovation for global health needs. Part one of this two-part article provides a foundational regulatory philosophy of technology and illustrates the purpose of regulatory science and tools practitioners can use to challenge current constructs on medical availability and drug/device development approval processes. Introduction Regulatory science is an emerging discipline used in the pharmaceut...
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    FDA’s Small Business and Industry Assistance Program: A Helping Hand to Small Pharma

    This article discusses services and programs offered by the US Food and Drug Administration (FDA), including a Small Business and Industry Assistance (SBIA) Program to help both large and small pharmaceutical companies in their journey through regulatory hoops and into the marketplace. Services include conferences, Webinars, tutorials, other online information and various communications services. Introduction Taking a drug product from proof-of-concept to the consumer’s...
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    RAPS Workshop Proceedings: Comparability Bridging Studies for Combination Products

    This article, based on a RAPS combination products workshop, discusses comparability, bridging, combination products and human factors and highlights participant presentations given during the workshop. The authors cover the FDA panel discussion, group exercises, case study experiences and considerations regarding bridging studies that have already been implemented into the study plans of sponsors in attendance. Those studies have the potential of being incorporated into ...
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    21st Century Cures Act and Acceleration of Device Approval

    This article discusses two critical provisions of the law meant to accelerate FDA approval of medical devices. It explains the benefits of the provisions, which have been criticized by consumer advocates in the past. Introduction It has been almost two years since the 21st Century Cures Act was signed into law, promising to modernize and accelerate the approval process for medical devices and other medical products. The US Food and Drug Administration (FDA) has attrib...