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Welcome to the December issue of RF Quarterly, featuring a selection of articles adapted from presentations at the 2025 RAPS Convergence in Pittsburgh, PA, on 7-9 October. The articles cover global regulatory pathways for orphan medical devices, best practices for effective collaboration around companion diagnostics, e-labeling in drugs and medical devices, and artificial intelligence (AI) in the regulatory setting – specifically, the use of generative AI (gen AI) for scaling up regulatory operations , and survey findings on how regulatory functions are adopting AI

Welcome to the September issue of RF Quarterly, focusing on global regulatory harmonization and including articles on early experiences in implementing version 4 of the electronic common technical document (eCTD v4.0); regulatory reliance in optimizing resources and accelerating patient access to therapies; and harmonization efforts in the medical device setting, specifically, quality standards, postmarket surveillance (PMS), and the role of global organizations in facilitating harmonization.

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.

Welcome to the March issue of RF Quarterly, which focuses on regulatory project management and includes articles on the biotech asset journey (from early development to market-ready success), the transition from bench science to project management, the RPM's role in the alliance setting, and tools and techniques for regulatory project management.

Welcome to the December issue of RF Quarterly, with selected presentations from RAPS Convergence 2024 adapted as articles focusing on eSTAR best practices, regulatory challenges for medtech start-ups, product quality review of biologics and biosimilars, navigating an IND clinical hold, human factors development, the regulatory-marketing partnership, and concurrent regulatory submissions.

Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI devices in clinical trials, AI-driven strategies for regulatory compliance medical devices, the role of data in AI governance, and machine learning (ML) best practices. As always, we hope the articles will provide guidance and resources for regional and global regulatory professionals. We thank the authors for their time and generosity in sharing their expertise and real-world knowledge and experience with the RAPS community.

Welcome to the June issue of RF Quarterly, which includes a selection of articles examining quality considerations for cellular and gene therapy (CGT) products and for generic drugs entering the Chinese market, implementation of an efficient and effective quality management system (QMS), and a three-part series on pharmaceutical stability testing.

Welcome to the March issue of RF Quarterly, a collation of articles on the EU Clinical Trials Regulation (EU CTR) examining the associated challenges and opportunities, accounts of early experiences and the lessons learned, strategic considerations, and practical approaches to the transparency stipulations.

Welcome to the December issue of RF Quarterly, featuring selected presentations from the 2023 RAPS Convergence and including articles on pediatric drug development, the FDA's proposed ACNU rule, clinical evidence from a notary body perspective, submission content considerations for combination products, and attributes for successful regulatory leadership.

Welcome to the September issue of RF Quarterly, which focuses on leadership in regulatory affairs. The issue includes articles on the leadership experience, leading without formal authority, essential regulatory leadership skills, and the regulatory leadership roles in small biotech companies.

Welcome to the June issue of RF Quarterly, which focuses on global health agencies and regulatory practice. The issue includes articles on post-Brexit UK medicines regulation; market exclusivity for orphan drugs in the US and EU; the Access Consortium; Canada's medical device regulatory framework; global expedited pathways for cellular and gene therapies; medical device cybersecurity regulations in China, Japan, and Singapore; and a regulatory outlook on artificial intelligence trustworthiness.

Welcome to the September issue of RF Quarterly in which global regulatory experts write about the role of artificial intelligence (AI) in regulatory practice, with a focus on global change management of AI-based medical devices, AI in regulatory intelligence knowledge management, synthetic data and the innovation, assessment, and regulation of AI medical devices, and digital transformation.

Welcome to the September issue of RF Quarterly in which global regulatory experts write about the key elements of regulatory strategy throughout the product lifecycle, CMS regulatory strategy, the application of project management strategies to postapproval CMC submissions, and medical writing strategies for aligning regulatory documents with strategic goals.