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2026 Issue 2

A bimonthly, peer-reviewed publication providing in-depth, evidence-based content, exclusive to RAPS members.

March-April 2026

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Welcome to the latest issue of the RAPS Journal of Regulatory Affairs, a bimonthly, peer-reviewed publication building on the success of its predecessor, RF Quarterly.

The Journal of Regulatory Affairs delivers evidence-based content to almost 30,000 regulatory professionals globally. The in-depth articles have a strong “how-to” subtext, making the Journal a key go-to resource and guidance for professionals in the real-world regulatory setting. For more information about the Journal and submitting an article, view author guidelines and information.

In this issue

Contributing authors examine the EU Artificial Intelligence Act in two articles – one focusing on the act’s scope and convergence/divergence with the EU Medical Devices Regulation, and the other, on its operationalization – as well as articles on engineering safety and effectiveness in drug-device combination products and regulatory considerations for pharmaceutical excipient selection.

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Table of Contents

1    Introduction
         Renée Matthews
         HTML

4    Navigating convergence and divergence between the EU MDR and EU AI Act
         Attrayee Chakraborty, MS, MSc, CQSP • Geethapriya Setty, MSOT, RAC-Devices, PMP, CMDA
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19    Build from the base: Operationalizing the EU AI Act through a decision‑tree approach
         Attrayee Chakraborty, MS, MSc, CQSP • Geethapriya Setty, MSOT, RAC-Devices, PMP, CMDA
         HTML

31    Engineering safety and effectiveness: A first-principles approach to drug-device combination products
         Fubin Wu, MS • Jiaying Shen, PhD • James Wabby, MHMS • Darin Oppenheimer, DRSc, FRAPS, RAC, PMP •
         Yu Tang, PhD • Pooja Kartik, BSCS
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49    Regulatory considerations for pharmaceutical excipient selection
         Yuri Ceragioli, MS
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All Journal Articles     RF Quarterly (2021-2025)     Monthly articles (2012-2025)

Previous issues of the Journal of Regulatory Affairs January-February 2026 (inaugural issue)

Contact: Renée Matthews, Managing Editor, and Anna Han, Content Editor, at [email protected]

Advertising: Visit RAPS Media Planner or contact Eric Gershowitz +1 410-584-1983  

Meet the Editorial Team

 

All Journal Articles

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Journal of Regulatory Affairs
18 Sep 2026

Journal of Regulatory Affairs: A guide for submitting articles

The Journal of Regulatory Affairs is an independent, peer-reviewed journal that delivers original, research-based content on emerging issues in the global regulatory landscape. The journal is a bimonthly (i.e., six times a year) publication that also publishes Online Only articles, which may be included in a subsequent bimonthly issue. It reaches an audience of 30,000 regulatory professionals globally. The journal was launched in January 2026 and is built on the success of its predecessor, RF Quarterly. 

Member Only
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Daniel Simpson, RAC (US, CAN)
15 Sep 2026

Diagnostics in limbo: Evaluating the new lab-developed test compliance landscape

This article discusses the current landscape of laboratory-developed tests (LDTs) following a federal court’s decision to vacate the FDA’s final rule, which represented the agency’s latest attempt to regulate this category of in vitro diagnostic (IVD) products. This article explores the history of the FDA’s efforts to regulate these tests, past and current enforcement trends, and best practices for developers and manufacturers to protect against compliance pitfalls.

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Renée Matthews
15 Sep 2026

Journal of Regulatory Affairs, September-October 2026

Welcome to the Journal of Regulatory Affairs, featuring articles on the proposed plausible mechanism framework, essential drug delivery output control strategies for drug/biologic combination products, the new lab-developed test compliance landscape for diagnostics, the use of real-world evidence in FDA medical device submissions, and pediatric frameworks in the US and EU.

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