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Pediatric plans are regulatory frameworks ensuring that the well-being of the pediatric population is adequately considered during the development of new medicinal products. With global harmonization, regulatory writing becomes critical in drafting compliant, ethical, and scientifically robust pediatric study strategies. This article provides an overview of the differences in pediatric plan requirements across the European Medicines Agency (EMA), Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), and the US Food and Drug Administration (FDA), highlighting the regulatory submission process, writing considerations, and common challenges encountered during plan development.

Regulatory writing is an important function in the development of new medicines. Documents must be carefully crafted to convey the sponsor's key messages for regulatory agencies to review. This article provides an introduction to regulatory writing, a case study of drafting a clinical overview, best practices, and an assessor's viewpoint in preparing documentation for regulatory submissions. Suggestions to streamline the authoring of clinical documents and the possibilities for applying AI in regulatory writing are also provided. Keywords – artificial intelligence, assessor's viewpoint, clinical overview, clinical regulatory writing, first-time quality

The digital IND/NDA/BLA is an innovative conceptual framework for regulatory applications that leverage in silico modeling using artificial intelligence, machine learning, and neural network technologies. These frameworks establish fully digital submission pathways where nonclinical simulation (no animal testing), in silico clinical pharmacology, clinical study modeling, and the creation of regulatory data and documents through submission are conducted in AI applications with expert human supervision. This article will examine generative artificial intelligence (gen AI) in producing regulatory documents, looking at time savings, current vendors, writing and editing style, the impact of company size, and augmentation. It also addresses vendor evaluation and cost/return on investment considerations. Keywords – biologics license application, digital submission, generative AI, investigational new drug, in silico, human supervision, new drug application

This article discusses the development and use of process infographics to streamline regulatory document development by increasing process efficiency and writer productivity. Process infographics in regulatory writing may enhance consistency and alignment across writers, help increase adaptability and reduce onboarding time, enhance clarity and comprehension of processes, and reduce errors and ambiguity. A thoughtful and carefully designed client-specific process infographic could easily become one of the most value-added visual tools in regulatory document development. Keywords – document development, process infographics, regulatory writing, visual workflow

Welcome to the June issue of RF Quarterly, which focuses on regulatory writing and includes articles on a clinical overview case study and key takeaways, generative AI in regulatory writing, considerations in writing for a regulatory audience, and using process infographics for streamlining regulatory document development.