• Feature ArticlesFeature Articles

    Separate Drug Approval in Children is not Based on Science

    This article discusses the flaws and historical roots of separate drug approval in adults and children, caused by exaggerated warnings of drug toxicities, which are appropriate for newborns, but not for all minors until they become adult. Hidden conflicts of interest include the American Academy of Pediatrics‘ (AAPs‘) desire for pediatric research funds, the regulatory authorities‘ vision for on-label pediatric drug prescriptions only and industry's desire for patent exte...
  • Feature ArticlesFeature Articles

    Performing a GMP Audit

    This article discusses the first-time experience of performing an audit from a regulatory professional’s perspective and is directed toward those who may never have participated in an audit. The author explains why audits should be conducted, summarizes key aspects of performing an audit and explains how findings might provide insight into the “bigger picture” of how hands-on manufacturing and good manufacturing practices are conducted in addition to being incorporated in...
  • Feature ArticlesFeature Articles

    FDA’s Drug Establishment Registration Process

    This article describes the detailed processes for firms manufacturing, preparing, propagating, compounding or processing drugs in the US or offering drugs for import to register with the US Food and Drug Administration (FDA). The author covers vital components of the registration process, including information on a firm’s DUNS Number, the Establishment Registration Structured Process Labeling (SPL) document, submitting the SPL and updating or changing an FDA registration....
  • Feature ArticlesFeature Articles

    Biosimilars, Consumer Advertising and Medical Device and In Vitro Diagnostic Regulations

    November feature articles covered: An Update on Biosimilars Global IVD Regulation and Changing Clinical Evidence Requirements Consumer Advertising and Medical Device Regulations Regulatory Information Management Regulatory Science Biosimilars and Regulatory Science Over the last 10 years, biosimilar acceptance has progressed significantly in Europe and the US although several organizations are advocating for more complete, accurate, transparent prescribing and ...
  • Feature ArticlesFeature Articles

    The Changing Clinical Evidence Requirements Under IVDR

    This article discusses the key elements of clinical requirements per the In Vitro Diagnostic Regulation (IVDR) and clinical planning. The IVDR emphasizes the need for manufacturers to demonstrate the clinical evidence for all medical devices. Introduction Whether a company is small or large, the idea of needing a clinical trial to demonstrate device performance can seem daunting. At the CEO level, concerns include cost, time to market and influencing the board of the ma...
  • Feature ArticlesFeature Articles

    Making Regulatory Information Management (RIM) Transformation Work

    This interview discusses taking a “process-centric approach” to Regulatory Information Management (RIM) and is based on presentations given by two regulatory professionals, Nancy Allen, a senior director in Global Regulatory Affairs at Eli Lilly and Paula Hudson, global implementation lead for RIM Systems Process at Eli Lilly. Allen and Hudson were presenters at the Veeva R&D Summit held on 19 September 2018 in Philadelphia, PA. RAPS: What were Eli Lilly’s goals in imp...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...
  • Feature ArticlesFeature Articles

    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...