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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...
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    Drug Pricing Transparency: The Conversation is Far From Over

    This article discusses the US government’s attempts to require drug pricing transparency in advertising. The authors explain the events following the Centers for Medicare and Medicaid Services (CMS) publication of a proposed rule for regulation to require drug pricing transparency. They outline recent initiatives by a number of other federal agencies to develop ways to inform the public about drug costs, efforts by the Pharmaceutical Research and Manufacturers of America (...
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    Form FDA 1572: Challenges and Opportunities

    This article discusses considerations for conducting global clinical trials under the US Food and Drug Administration’s Form FDA 1572, an agreement signed by the Principal Investigator (PI) to provide certain information to the sponsor and ensuring the sponsor will comply with FDA regulations related to the conduct of the clinical investigation of drugs and biologics. Some national authorities will not allow their investigators to sign Form FDA 1572 as from their perspecti...
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    The Transformation of Digital Health: What it Means for Regulatory Professionals

    Articles throughout November focused on what the changing digital health landscape, including big data, means for regulatory professionals. Leaders in the digital health space shared their insight and best practices on the challenges and opportunities of implementing digital health solutions, data safety and data risk in the digital healthcare sector and global digital drug information sources. Authors presented the impact of Software as a Medical Device (SaMD) on commerci...
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    Emerging Digital Health Solutions: Inherent Challenges in the Technology Driven World

    This article explores the challenges of digital health solutions and emphasizes the appropriate controls necessary to help mitigate the risks and ensure companies are adhering to the growing needs of regulators and industry best practices.   Introduction   The opportunities and challenges in technology are driving explosive breakthroughs for digital health solutions in our technologically focused society. The accessibility, convenience and mobility of digital healt...
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    Developing Digital Drug Information Based on Real World Effectiveness Tests: What Patients Really Need

    This article discusses the increase in digital drug information in both the US and EU as a complement to product labeling and how patients might benefit. The author reviews his study of digital drug information sources using patient participants who offered feedback on their experiences using web-based drug information both from the US and European Union. Topics covered in the study and reported here include information on digital formats, patient trust in drug information...
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    Driving Innovation, Mitigating Risk: The Path Forward in Building Consumer Digital Health and Safety Standards

    This article discusses issues of data safety and data risk in the digital healthcare sector. The authors cover digital health technologies and trends, issues and risks related to digital health privacy, foundational data regulations and new frontiers and strategies for building digital health governance and consumer protection.   Introduction   Digital health continues to dominate private investment, political rhetoric, regulatory interest and public conversation....
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    Real Innovation at FDA? Implications of a Changing Digital Health Regulatory Landscape

    This article discusses the history of combination product regulations in the US with a focus on the most recent FDA guidance for the regulation of Software as a Medical Device and the implications for commercial developers of medical devices and software.   Introduction   Navigating the regulatory pathway for traditional healthcare products like drugs and devices is time consuming and complex, but relatively well understood. FDA maintains a clear role in regulation...
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    Big Data and its Impact on the Pharmaceutical Industry

    This article defines “big data” and discusses its impact on the pharmaceutical industry regarding its application and usefulness. The author covers several areas in which big data has had a profound impact, such as in genomics, clinical trial monitoring, clinical monitoring and pharmacovigilance. He concludes by touching on big data and its relationship to the regulatory professional.   Introduction   The internet has provided a convenient way to share information ...
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    Regulatory Cybersecurity Requirements for Medical Devices

    This article discusses the relevance of cybersecurity to the healthcare industry, cybersecurity requirements presented by governing bodies and industry best practices for medical devices. Introduction Advancements in medical device technology has allowed for services, initiatives and changes in healthcare delivery to evolve at a break-neck pace. Smartphones are increasingly integrated into patient care planning, providing internet connectivity to share data with Heal...
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    The Continued Importance of Consumer Access to Chinese Medicine in a Changing Climate

    This article discusses the need for continued researcher access to Chinese medicinal herbs as the need for new options to treat febrile disease increases. The author cites global warming and climate change statistics as potentially responsible for the increase in tropical diseases for which traditional Chinese medicine has been used for centuries. She also reviews policies from various agencies that govern the use of such herbal medicines and supplements and concludes that...
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    Evolving Global Regulatory Landscape, Strategies and Best Practices

    October feature articles reported on a number of timely issues facing regulatory professionals today, including the advantages of using periodic safety update reports, practical solutions to pharmaceutical labeling challenges and best practices and strategies to manage global projects. Experts discussed a process to reform the medicinal products authorization system in China, illustrated the the need for regulatory requirements for ‘herbasimilars’ and introduced readers ...