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  • Feature ArticlesFeature Articles

    April’s Regulatory Focus: Specialist vs. generalist, RI, and more

    Feature articles during April examined the roles of the regulatory specialist and generalist and the application of regulatory intelligence (RI) in managing the new EU In Vitro Diagnostic Medical Devices Regulation (IVDR), developing an in-house regulatory database in the oncology setting, and strategic planning. Also included are articles on expedited regulatory pathway options, selecting control groups in pediatric clinical trials, and the role of artificial intelligence...
  • Regulatory NewsRegulatory News

    ICH drafts guideline on pediatric extrapolation in drug development

    The International Council for Harmonization (ICH) on Tuesday released a draft ICH E11A guideline that establishes a framework for extrapolating drug development data from adult trials to the pediatric population.   “This new ICH guideline aims to promote international harmonization of methodologies and strategies to incorporate paediatric extrapolation into overall drug development plans and to improve the speed of access to new drugs for paediatric patients, while l...
  • Feature ArticlesFeature Articles

    Considerations for selecting control groups in pediatric clinical trials

    ICH E10 provides specific guidance on the choice of control groups for clinical trials, but there are additional considerations for choosing a control group for a pediatric trial. In this article, the author looks at different types of control groups and the specific challenges that present when considering the design for a pediatric trial, such as the medical condition being treated, the potential patient population, suitability of comparators, and availability of real-wo...
  • Feature ArticlesFeature Articles

    December’s Regulatory Focus: Advertising, promotion, and labeling

    Feature articles during December focused on advertising, promotion, and labeling (APL), examining regulatory review of advertising on streaming media, the role of the regulatory A&P professional, the importance of metrics in APL, and the regulatory outlook for telehealth A&P. Also included is the second part of a two-part series on EU regulation of herbal products, examining quality, safety and efficacy, and postmarket surveillance.   Last year this time, the issue co-...
  • Feature ArticlesFeature Articles

    The regulatory outlook for telehealth advertising and promotion

    The global pandemic has increased the use of telehealth and accelerated its acceptance into mainstream healthcare. However, the regulatory landscape has yet to fully catch up with this expansion of telehealth. This article discusses some of the potential advertising and promotional regulatory implications as telehealth becomes a mainstay in the ever-evolving healthcare sector. The article explores the advertising and promotion of off-label drug prescriptions by telehealth ...
  • Feature ArticlesFeature Articles

    Regulatory advertising & promotion: Bringing value beyond the day-to-day

    While the primary goal of the clinical development team is to obtain product approval, companies must have a broader vision that supports the complete product lifecycle. Experts in regulatory advertising and promotion (A&P) have a detailed knowledge of the US Food and Drug Administration (FDA) requirements for product promotion. Beyond supporting the promotional review process, the unique skill set of regulatory A&P should be applied to other critical activities, including...
  • RF Quarterly
    Feature ArticlesFeature Articles

    RF Quarterly, December 2021: Key takeaways from RAPS Convergence 2021

    Welcome to the December issue of RF Quarterly which focuses on key takeaways from RAPS Convergence 2021, including patient-focused approaches in regulatory decision making and drug development, the transition from convergence to harmonization for global pharmaceutical regulatory requirements, pediatric drug development, and regulatory and clinical strategies.   Patient perspective and global harmonization There is increasing recognition of the importance of patients...
  • RF Quarterly
    Feature ArticlesFeature Articles

    Pediatric drug development: Increasing success and overcoming obstacles

    This article discusses pediatric drug development in the EU and US, with an emphasis on overcoming regulatory obstacles. The authors present the commonalities and differences between US and EU regulations and guidelines and examine the legislative acts and subsequent regulatory requirements, while outlining the necessary steps for successful implementation of pediatric drug clinical trials. They conclude with a discussion of three case studies that highlight strategic init...
  • Feature ArticlesFeature Articles

    The RACE is on: Opportunities in pediatric oncology product development

    Pediatric oncology patients continue to have significant unmet medical need. Although the Pediatric Research Equity Act (PREA) mandated evaluation of new drugs for pediatric patients, the rarity and uniquity of pediatric cancers allowed for waivers or exemptions from PREA requirements. The passing of FDA Reauthorization Act amendments in 2017 included the Research Acceleration for Cure and Equity Act, which expands the scope of oncology products subject to PREA. Sponsors d...
  • Feature ArticlesFeature Articles

    Global pediatric development: Challenges, potential solutions, and opportunities

    The US and EU require sponsors to evaluate their drugs for use in children. The low prevalence of many conditions in children means sponsors commonly want to conduct one pediatric development program that satisfies the requirements of both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). However, multiregional pediatric development is challenging. This article will describe some of the challenges associated with pediatric development, offer po...
  • Feature ArticlesFeature Articles

    Strategies for pediatric clinical trials and drug development

    This article discusses the considerations for designing and conducting pediatric clinical trials from a pediatrician’s perspective. The author covers pediatric subpopulations, issues related to age, endpoints, and pharmacokinetic considerations, while presenting practical solutions and ethical considerations. Patient and family‒centric approach to studies and engagement with patient advocacy groups are also discussed. The author concludes with some recommendations about pe...
  • Regulatory NewsRegulatory News

    FDA announces stronger warnings on breast implant labels

    The US Food and Drug Administration on 27 October announced new labeling, including boxed warnings, to facilitate informed consumer decision-making regarding the risks of breast implants.   FDA is also restricting the sale and distribution of breast implants to providers who agree to provide patients with adequate information on their risks by reviewing a decision checklist with patients. The physician performing the breast implant must sign the checklist, and patien...