Current Issue, September-October 2026
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.
In this issue, contributing authors examine the proposed plausible mechanism framework, essential drug delivery output control strategies for drug/biologic combination products, 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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Table of Contents
1 Introduction
Renée Matthews
5 The proposed plausible mechanism framework: Potential promises and challenges
Marilyn Gafford, PharmD ▪ Ronald Hall, PharmD, MSCS, RAC ▪ William C. Putnam, PhD, RAC
15 Optimizing EDDO control strategies for drug/biologic combination products
Rumi Young, MENG ▪ Ashley Boam, MSBE ▪ Anna Karina Busch, PhD ▪ Susan Clemmons, MS ▪ Willy Liou, MS ▪ Shruti Mistry, MS
27 Diagnostics in limbo: Evaluating the new lab-developed test compliance landscape
Daniel Simpson, RAC-US,CAN
37 Real-world evidence in FDA medical device submissions: Considerations for regulatory decision making
Anuja Yardi, MS, MPharm, RAC-US
52 Comparing EU and US pediatric frameworks at a time of reform
Samantha Gastine, MSc ▪ Nadia Boehringer, MSc, MBA ▪ Anne-Valérie Faucher, MSc
All Journal Articles RF Quarterly (2021-2025) Monthly articles (2012-2025)
Previous issues of the Journal of Regulatory Affairs
July-August 2026
May-June 2026
March-April 2026
January-February 2026 (inaugural issue)
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