• TrackersTrackers

    COVID-19 therapeutics tracker

    A year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab as well as Regeneron’s casirivi...
  • Feature ArticlesFeature Articles

    April’s Regulatory Focus: Professional and career development

    Feature articles during April focused on the regulatory profession and specifically, professional development and career advancement. Included were articles on the mid-career transition from research scientist to regulatory professional, continuous professional development and the value of graduate-level qualifications, and findings from two surveys on different aspects of the profession. Other articles examined communication – one on persuasive skills, another on dissemin...
  • Feature ArticlesFeature Articles

    Value of an RA qualification in continuous professional development and career progression

    Continuous professional development (CPD) is important for employee personal development and is of strategic value for organizations. Having qualified and knowledgeable personnel can help deploy strategy and yield competitive advantage in the marketplace. This article presents the results of a qualitative and quantitative study on the progression and experiences of industry-based graduates who completed a masters in regulatory affairs. The results demonstrate that regulato...
  • Feature ArticlesFeature Articles

    The PhD scientist’s pathway into regulatory affairs

    Making a transition from a life and health science research scientist to a regulatory affairs professional can be challenging. It is difficult to gain the requisite experience in an academic or industry research setting. However, the combination of an advanced science degree, transferable skills, and professional experiences can make this transition attainable.   Intellectual curiosity is often the impetus for pursuing a doctorate degree (PhD). The desire to learn a su...
  • RF Quarterly

    Strategies for clinical development planning

    Clinical development planning can be thought of as the integrated design and structuring of the steps from the first phase 1 study for the initial assessment of safety, to one or more phase 2 studies for better understanding the product’s pharmacology, safety, and effectiveness, to a phase 3 definitive demonstration of efficacy and safety. Optimal strategy can be informed by creating a vision for the product in the form of a target product profile, examining precedence (wh...
  • ReconRecon

    Recon: Kerfuffle over WHO's Wuhan mission; BMS inks $1.3 B cancer deal

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US New, Daily Coronavirus Cases Drop Below 100K For First Time In Months ( NPR ) U.S. Continues To Accelerate Vaccination Strategy ( NPR ) Seven coronavirus variants potentially similar to UK type have been detected in US: study ( The Hill ) ( NYT ) Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic ( NPR ) Pentago...
  • Regulatory NewsRegulatory News

    New toolbox available for EMA's PRIME designees

    The European Medicines Agency has released a draft guidance to assist drug developers using its Priority Medicines (PRIME) scheme to accelerate authorization of new therapies.   “Experience to date has shown that applicants face challenges to complete quality and manufacturing development and data requirements during development of products in early access approaches,” wrote EMA in the executive summary of the guidance.   Challenges for those developing breakthroug...
  • Regulatory NewsRegulatory News

    Perspective: Drug price transparency in the Biden era

    The Trump administration’s efforts to increase drug price transparency are likely to survive the transition to the Biden administration, according to a perspective piece published 13 January in the New England Journal of Medicine . Included in the Transparency in Coverage final rule, issued in late October 2020, the drug price transparency provisions aim to require that health insurers publish list prices and historical net prices for prescription drugs. The inform...
  • Regulatory NewsRegulatory News

    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...
  • Regulatory NewsRegulatory News

    EC’s new pharmaceutical strategy highlights support for innovation, R&D

    The European Commission (EC) has adopted its pharmaceutical strategy for Europe. The announcement follows a period of consultation earlier this year and meets the EC’s goal of finalizing the strategy by year’s end.   The strategy is not focused on the COVID-19 pandemic, but strategies and considerations included in the document were informed by the impact of the novel coronavirus in Europe and globally.  The primary objectives of the strategy fall into four categories. ...
  • Regulatory NewsRegulatory News

    Experts propose changes to FDA’s Accelerated Approval Program

    A new white paper from the Friends of Cancer Research offers a blueprint for reimagining the US Food and Drug Administration (FDA) Accelerated Approval Program for drugs and biologics that treat serious and life-threatening illnesses. The white paper , released during the group’s annual meeting, recommends explicitly adding a more comprehensive risk-benefit assessment to the surrogate endpoints currently used as the basis for approval, a framework that would move the U...
  • Regulatory NewsRegulatory News

    EMA's CHMP gives Gamifant a second thumbs down; approves five new medicines

    In its November meeting, a committee of the European Medicines Agency gave its second thumbs down to the monoclonal antibody Gamifant (emapalumab), confirming a July 2020 negative opinion on the Novimmune SA drug.   The US FDA approved Gamifant for pediatric use in primary hemophagocytic lymphohistiocytosis in November 2018; this was the same indication for which EMA has twice declined authorization.   EMA’s human medicines committee (CHMP) had positive recommendat...