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Journal of Regulatory Affairs

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

Current Issue, November-December 2026

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Welcome to the latest issue of the RAPS Journal of Regulatory Affairs.

This member-exclusive journal delivers original, peer-reviewed content on emerging issues in the global regulatory landscape. Its research-based, solutions-focused articles are intended as valuable, go-to resources and guidance for professionals in the real-world regulatory setting.

The journal will also publish online-only articles, which may be included in a subsequent bimonthly issue. It reaches 30,000 regulatory professionals globally. For more information about contributing to the journal, please view author guidelines and information.

Contributing authors explore the use of AI in regulatory affairs, iterative medical device software development in the US and EU, integrating China into global drug development, Class I medical device recall trends, and oncology accelerated approvals and withdrawals.

Table of Contents

1   Introduction
     Anna Han

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3   [Sponsored content] Canada’s interim clinical trial policy: What sponsors and investigators need to know
     Scott Sawler, LLB, LLM, MBA
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5   Building AI literacy for medical device regulatory affairs professionals
     Geethapriya Setty, MSOT, RAC-Devices, PMP • Jay Vaishnav, PhD, RAC-Devices, FRAPS
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16  AI in regulatory writing: Examining critical pitfalls and implications
     Red Thaddeus D. Miguel, MD, MBA, MSc, RAC-Drugs, RCC-MDR • Rami Ali, MScPH • Manal El Joumaa, MSc
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25 Understanding iterative medical device software development in the US and EU
     Wybe Hoffmann, MSc • Patrick Mahoney, MBA, RAC
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42 Regulatory pathways for approving foreign drugs in China: A global integration perspective
     Wenny Du, MS, MBA, RAC • Hamish King, BA, LLB, RAC • Xiao Michelle Meng, PhD, RAC
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61 Trends in FDA Class I medical device recalls over an eight-year period
     Tabitha Y. Shen, PhD • Autumn J. Bullard, PhD • Ekaterina Galkina Cleary, PhD • Alex Peer, PhD • Marta L. Villarraga, PhD, RAC
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73 Accelerated approval pathway for oncology: Summary of approvals and withdrawals, 1992-2026
     Sarah Sejoro, MSc, MPH • Karl E. Peace, PhD
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All Journal Articles     RF Quarterly (2021-2025)     Monthly articles (2012-2025)

Previous issues of the Journal of Regulatory Affairs
September-October 2026
July-August 2026
May-June 2026
March-April 2026
January-February 2026 (inaugural issue)

Submit an article View author guidelines and information

Contact  Editorial office at [email protected]

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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
Blood samples_lab_diagnostic.jpg
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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