• 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...
  • 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...
  • Feature ArticlesFeature Articles

    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...
  • Regulatory NewsRegulatory News

    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...
  • Feature ArticlesFeature Articles

    Advanced therapies: ‘Trip hazards’ on the development pathway

    This article concerns the development of advanced therapies and the challenges and complexities of getting them through the developmental pathway, which the authors call “the trip.” The authors examine at strategic levels the importance of some of the fundamental building blocks for the development program and highlight some commonly encountered challenges (trip hazards) for cell and gene therapies and offer “bench-to-bedside” and chemistry, manufacturing, and controls (CM...
  • Feature ArticlesFeature Articles

    Risk management, drug shortages and the EU portal for clinical trials

    Feature articles during May focused on risk management and mitigation in dealing with contractors and vendors and included articles on best practices in good vendor management, use of risk management to support outsourcing activities, testing in-house versus outsourcing, and outsourcing in regulatory operations. Also included were in-depth examinations of challenges and opportunities in “bespoke” therapies, a critical appraisal of drug shortages in Germany and an update on...
  • Feature ArticlesFeature Articles

    Bespoke therapies – opportunities, challenges, and hope

    This article discusses the advent of bespoke therapies, defined as the tailoring of medical treatment to the individual characteristics or symptoms and responses of a patient during all stages of care and as a new frontier beyond personalized medicine. The author covers the revolutionary genetic tools implementing such therapies and the clinical and nonclinical safety perspectives for bespoke therapies. The author concludes that with bespoke therapies we are entering a new...
  • Feature ArticlesFeature Articles

    Drug shortages in Germany ‒ A critical appraisal

    This article discusses drug shortages in Germany, the root causes of production problems with active pharmaceutical ingredients, and drug product manufacturers. The authors offer analysis from the perspective of a medium-sized generic drug manufacturer. They outline a range of reasons for the shortages, all of which point to a “broken marketplace.” The authors conclude with a discussion of mitigation activities and address the current COVID-19 pandemic. They warn that drug...
  • Regulatory NewsRegulatory News

    Pelosi Drug Pricing Bill Advances on Party-Line Votes

    Two House committees on Thursday advanced on party-line votes Speaker Nancy Pelosi’s (D-CA) bill to allow for the negotiation of certain medicine prices as part of plans to bring down costs in the US. No major amendments were adopted in either the Energy & Commerce or the Education & Labor committees’ meetings, although the amendments in the E&C meeting ranged from carving out specific disease treatments from negotiations to requiring the Health and Human Services Sec...