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  • Feature ArticlesFeature Articles

    Challenges to contemporaneous FDA approval for companion diagnostics and their drug partners

    Abstract Ideally, the drug development pathway aligns with the companion diagnostics (CDx) validation on stages and steps in that the efficacy of the drug and CDx are clinically validated together as part of a phase 3 trial. However, the market is trending toward earlier submissions from the drug side. Specifically, if efficacy is shown in a phase 2 study, then a new drug application (NDA) or biologics license application (BLA) could be submitted using this information,...
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    Getting ready for the EU IVDR transition

    This article discusses a manufacturer’s challenges and solutions to preparing currently marketed in vitro diagnostic (IVD) devices for new requirements under the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746.   Introduction It is daunting, in the best times, to work together to develop and manufacture IVD tests and instrumentation and coordinate their readiness for regulatory review. To get functional area heads in a global company to review and summarize ...
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    FDA warning letters in 2020 reveal concerns around purity, investigations, and data integrity

    Warning letters issued by the US Food and Drug Administration (FDA) provide important context for regulatory intelligence professionals in the pharmaceutical manufacturing space. In this article, the authors review 2020 warning letters related to good manufacturing practices (GMP) and provide examples of common citations that point to larger trends in FDA enforcement. Among the warning letters, citations frequently pointed to inadequate qualification of supplier certificat...
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    Advanced therapies: Navigation and application of EU and US guidelines during product development

    Continued progression and understanding in the development of advanced therapies has led to a significant increase in the number of products and types of indication under investigation, particularly for treating serious and life-threatening conditions. Although the principle regulatory requirements and guidance, as issued for traditional biologic products, can be generally applied, advanced therapies require additional regulatory and strategic considerations because of the...
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    October’s Regulatory Focus: The regulatory toolbox

    Feature articles during October focused on the regulatory toolbox – the tools for routine regulatory work, from the basics for needed by newcomers to the specialty items needed by seasoned pros  working in the EU and the US. The articles collectively provide accessible, evidence-based, and (mostly) free informational tools, such as health agency guidances and best practices guidelines and advice on effective communication and career options and development.    Setting u...
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    Making the transition from regulatory manager to regulatory consultant

    This article is about making the transition from company-based regulatory management to regulatory consultancy. It describes the differences between the two roles and provides hands-on, detailed guidance on best practices and how to prepare and tool up for consulting. The author presents a case study demonstrating step by step how a consultant drew on those practices and tools to assist an overseas client in successfully marketing an existing medical device in the US.   ...
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    US-focused regulatory toolbox: The basics

    This article examines regulatory tools found mostly on the US Food and Drug Administration’s (FDA’s) website for use by regulatory affairs professionals interested in drug products and medical devices marketed in the United States.   FDA guidance documents 1 Guidance documents represent the agency’s current thinking or interpretation of a particular policy or topic. They are an especially useful tool for RA professionals dealing with issues such as drug development ...
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    EU regulatory tools for RA professionals

    This article provides information on the key sources of information needed for understanding and keeping up-to-date with the European regulation of healthcare products, including medical devices and in vitro medical devices (IVDs), pharmaceuticals/medicinal products, and substances of human origin (blood, tissues, cells, and organs).   Introduction Regulatory professionals who need to understand the European regulation of healthcare products will find that the main s...
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    Starting out: A beginner’s toolkit of US regulatory resources

    This article offers a selection of 28 publicly available resources for newcomers to the regulatory profession. The author recommends many US Food and Drug Administration (FDA) websites, including information and guideline resources from a number of the agency’s centers and their respective websites and searchable databases.   Introduction The FDA website is the go-to platform for US-related regulatory information ( Table 1 [1]). This multipurpose learning and resea...
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    Getting to the point: Achieving clear communication with health authorities

    This article discusses the critical need for clear, precise, and consistent communication on the part of regulatory professionals in interactions and submissions with health authorities. It presents various approaches and offers examples for the regulatory professional to draw on to improve the clarity of such communications.   Introduction As a regulatory professional, one is constantly reaching for and achieving new goals. Whether it is initiation of a first-in-hum...
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    A regulatory anomaly: The NDA for water

    This is the story of a Code of Federal Regulations monograph for eyewash and a second regulation, which required a new drug application (NDA) for any drug sterilized by gamma irradiation. Both of these regulations did not take into consideration that water is a drug. Therefore, eyewash sterilized by gamma irradiation required an NDA. It took almost 14 years to eliminate the requirement of an NDA for eyewash sterilized by gamma. During this period, the company filed and rec...
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    September’s Regulatory Focus: Countdown to EU MDR and IVDR

    Feature articles during September focused on aspects of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with articles on compliance and manufacturer obligations, and perspectives examining the current status of the regulations. The issue also included the second part of the cell and gene therapy series, and an article on regulatory tools for generic drug companies.   MDR and IVDR, close up Full implementation of MDR is slated for ne...