RF Quarterly Archive (2021-2025)

This article reports the findings from a 2025 benchmarking survey on the adoption of regulatory artificial intelligence (regulatory AI) across pharmaceutical and life sciences industries to learn how regulatory affairs organizations are turning their AI ambitions into action. Industry leaders are investing in AI solutions for regulatory intelligence, drafting assistance, and research assistance, unlocking measurable gains in efficiency, compliance, and insight. Although adoption remains uneven, with many organizations seeking clearer evidence of return on investment (RoI), some are realizing measurable impact. The findings highlight the emerging practices and strategies defining the next era of regulatory excellence and how organizations can improve implementation and scale readiness during the AI revolution.

Orphan medical devices are devices that are used for a small patient population due to the rarity of the indications. Due to the smaller patient population, manufacturers face unique challenges in generating sufficient clinical data for regulatory submission. This article discusses the Humanitarian Use Device (HUD) program of the US Food and Drug Administration (FDA) and the orphan device program introduced in the EU in 2024.

The successful development and deployment of companion diagnostics (CDx) requires effective interactions between four different parties: the therapeutic developer, the diagnostic manufacturer, the drug regulatory body, and the diagnostic regulatory body. Ensuring effective collaboration requires that the parties understand each other's roles, responsibilities, and goals. This article highlights therapeutic, diagnostic, and regulatory perspectives of CDx and emphasizes the importance of open and transparent communication to support successful collaboration and patient access to these critical therapeutic tools.

This article discusses the shift from paper labels to electronic labels and explains how manufacturers and regulators may modify the way important product information is communicated. It examines the status of regional initiatives in the US, Singapore, and the EU; describes the operational and regulatory obstacles to global adoption; and suggests feasible, evidence-based implementation strategies. To achieve a globally harmonized e-labeling ecosystem, the discussion emphasizes the importance of stakeholder collaboration, data integrity, accessibility, and sustainability.

The regulatory affairs (RA) function within the medtech industry is managing an unprecedented surge in compliance complexity and volume, driven by major regulatory shifts like the EU's Medical Device Regulation and In Vitro Diagnostic Regulation and increased guidance from the US Food and Drug Administration (FDA). At the same time, generative artificial intelligence (genAI) has emerged, promising significant efficiency gains: up to a 75% reduction in content creation and billions of dollars in annual productivity savings, according to some sources. This article provides an overview of the role of genAI in regulatory operations, benchmarking model performance in RA-specific contexts, and highlighting key application areas. It also provides practical, actionable guidance for RA professionals and executives on defining robust use cases, securing executive buy-in, essential upskilling, and adopting best practices to ensure the safe, effective, and compliant implementation of genAI.

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.

The International Council for Harmonisation (ICH) has endorsed the eCTD – the electronic common technical document – as the message standard for electronic submissions. This article presents an in-depth analysis of the implementation journey of the eCTD version 4.0 (eCTD v4.0) based on industry involvement in the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the US Food and Drug Administration (FDA) technical pilots. It highlights the importance of harmonizing metadata, managing two different eCTD formats during the transition period, and ensuring interoperability between vendor tools and regulatory systems. Analyses of the eCTD v4.0 specifications are based on the authors' practical experience in submitting sequences in eCTD v4.0 format in Japan, industry involvement in the planning and preparation of eCTD v4.0 implementation, and limited participation during PMDA and FDA technical pilots.

Regulatory reliance allows national regulatory authorities (NRAs) to draw on the scientific assessments and decisions of trusted, more experienced regulators while preserving their sovereign decision-making authority. This approach streamlines approvals, optimizes resources, and expands timely patient access to medicines and medical devices. Reliance also complements harmonization efforts, strengthens regulatory systems, and builds trust among stakeholders. This article provides an overview of reliance principles, highlights global and regional initiatives, and explores their implications for regulatory efficiency and capacity building. By fostering collaboration and mutual trust, regulatory reliance contributes to equitable and improved patient access to medicines and medical devices.

Medical device manufacturers are required to undertake a range of postmarket surveillance (PMS) activities to comply with regulatory requirements to ensure the safety and performance of their devices in the marketplace. This review outlines the requirements for key international jurisdictions and harmonization efforts underway to reduce impediments to market access.

Global regulatory harmonization in the medical device sector is essential for ensuring timely patient access to safe and effective technologies while reducing redundant regulatory burdens. This article explores the evolving landscape of harmonization efforts, focusing on the convergence of regulatory frameworks across key markets such as the EU, US, and Asia-Pacific region. It highlights the role of international initiatives such as the International Medical Device Regulators Forum (IMDRF), reliance models, and mutual recognition agreements in shaping a more unified global approach. Furthermore, the article examines how regulatory reliance, streamlined documentation, and shared clinical evidence are being leveraged to accelerate approvals and maintain compliance. It also addresses the challenges of aligning diverse regulatory expectations, particularly in postmarket surveillance (PMS), labeling, and quality system requirements. The discussion underscores the importance of cross-functional collaboration, digital transformation, and proactive engagement with notified bodies and competent authorities, emphasizing the importance of a strategic, risk-based approach to global regulatory operations that balances innovation, patient safety, and market agility.

Over the past decade, the global landscape of medical device quality management has undergone a significant transformation. While ISO 13485:2016 provides a common foundation, regional adaptations create overlapping audits and complex compliance pathways. The Medical Device Single Audit Program (MDSAP) and unique device identification (UDI) initiatives have advanced harmonization but remain limited by narrow scopes and database interoperability challenges. Quality management system (QMS) reforms in key markets highlight a growing emphasis on accelerating patient access. This article provides an overview of current quality trends, identifies persistent gaps, and offers a prognosis for future convergence.

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.

The regulatory project manager role in the pharmaceutical, biopharmaceutical, biotechnology, and medical device industries has become a defined career path. This article explores the tools and technologies that assist RPMs in schedule, risk, resource, and communication management. It highlights the importance of project plans, risk mitigation strategies, resource allocation, and effective communication for successful regulatory project management.

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.

Regulatory project managers (RPMs) are in demand across the pharmaceutical, biotech, and medical devices industries. Leaving bench science for an RPM position is an exciting career move that requires the acquisition of specific knowledge and skills, some of which are transferable from bench science and others that must be acquired. This article discusses the transition from bench science to regulatory project management in the drug and medical devices industries.

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.

While most clinical holds are eventually lifted, the associated time and cost can be substantial. Fortunately, experience has shown that the risk and impact of a hold can often be mitigated through sound regulatory strategy. This article presents various studies of holds associated with each of the core IND disciplines (nonclinical, clinical, and quality), emphasizing what is needed for a complete application and the value of strategic thinking in the evaluation and mitigation of identified risks.

This article discusses the importance of human factors engineering (HFE) in the development of drug-led combination products. It highlights the unique challenges and areas of ambiguity faced by industry in the implementation of a robust HFE program and provides suggestions that may be adopted to develop robust regulatory strategies to navigate these ambiguities.

A successful 510(k) submission can make or break a product's entry into the medical device market. This article provides insights on the best practices for preparing and submitting a 510(k) submission using the US Food and Drug Administration's (FDA's) eSTAR program. The authors provide guidance on how to create a 510(k) submission that will have the greatest chance of achieving a substantial equivalence determination. It includes suggestions on how to keep the submission organized, use the help texts offered by eSTAR, and identify appropriate standards and guidances for a specific medical device.

This paper summarizes the findings from an in-depth analysis of biologics and biosimilars license applications reviewed by Center for Drug Evaluation and Research (CDER). By understanding the common regulatory findings, review issues, and postmarketing commitments/requirements related to the chemistry, manufacture, and controls (CMC) information provided in Module 3 of a biologics license application (BLA), regulatory professionals can better prepare their submissions and potentially shorten approval timelines. The recommendations are intended to guide small biotech companies through the complexities of CMC submissions, ensuring that the quality aspects of their applications meet US Food and Drug Administration (FDA) standards and contribute to a successful outcome.