Impact of regulatory science on global public health by Meghal Patel, Margaret Ann Miller

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Regulatory Qualification of a Cross-Disease Digital Measure: Benefits and Challenges from the Perspective of IMI Consortium IDEA-FAST by David Nobbs, Wojciech Piwko, Christopher Bull, Francesca Cormack, Teemu Ahmaniemi, Sebastian C. Holst, Meenakshi Chatterjee, Walter Maetzler, Stefan Avey, Wan Fai Ng

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Regulatory Science Needs for Neonates: A Call for Neonatal Community Collaboration and Innovation by Susan K McCune, Yeruk Ager Mulugeta

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Decisions of the FDA on premarket tobacco product applications: Changes in the number of unique devices and liquids used by US adults who frequently use electronic nicotine deliver... by Elizabeth Crespi, Jeffrey J. Hardesty, Qinghua Nian, Joanna E. Cohen

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Use of cardiovascular registries in regulatory pathways: perspectives from the EU-MDR Cardiovascular Collaboratory by Ernest Spitzer, José M. de la Torre Hernández, Ingibjörg Jóna Guðmundsdóttir, Eugene McFadden, Claes Held, Claude Hanet, Eric Boersma, Claire B. Ren, Victoria Delgado, David Erlinge, Armando Pérez de Prado, Jeroen J. Bax, Jan G.P. Tijssen

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How many minors are participating in clinical research today? An estimate and important lessons learned by Richard F. Ittenbach, Jeremy J. Corsmo, Alison D. Kissling, Arnold W. Strauss

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Human cytomegalovirus and transplantation: drug development and regulatory issues by Megan McIntosh, Benjamin Hauschild, Veronica Miller

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Expanding Citizen Science: Community Action Without Primary Data Collection by Robert Evans, Nick Hacking, Jamie Lewis

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Opinion: regulatory genotoxicity: past, present and future by Makoto Hayashi

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Toward a Regulatory Qualification of Real-World Mobility Performance Biomarkers in Parkinson’s Patients Using Digital Mobility Outcomes by Marco Viceconti, Sabina Hernandez Penna, Wilhelmus Dartee, Claudia Mazzà, Brian Caulfield, Clemens Becker, Walter Maetzler, Judith Garcia-Aymerich, Giorgio Davico, Lynn Rochester

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Temporal Trends and Factors Associated With Cardiovascular Drug Development, 1990 to 2012 by Thomas J. Hwang, AB, Julie C. Lauffenburger, PharmD, PhD, Jessica M. Franklin, PhD, Aaron S. Kesselheim, MD, JD, MPH

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Advancing medical device regulatory reforms for innovation, translation and industry development in China by Xu Song, Minxia Hu, Bin Li, Kai Zhang, Xingdong Zhang, Lanming Wang

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Review on Drug Regulatory Science Promoting COVID-19 Vaccine Development in China by Zhiming Huang, Zhihao Fu, Junzhi Wang

Subjects: “…Regulatory science…”
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Structured content and data management—enhancing acceleration in drug development through efficiency in data exchange by Jill Beierle, Marquerita Algorri, Marisol Cortés, Nina S. Cauchon, Andrew Lennard, J. Paul Kirwan, Shirley Oghamian, Michael J. Abernathy

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A Methodology to Integrate Regulatory Expertise, Research and Education to Accelerate Biomedical Device Translation by Diana Easton

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Bridging Gaps in Oncology: Comparative Analysis of Development and Approval Pathways for Anticancer Drugs and Companion Diagnostic in the United States and Japan by Kaku Saito, Mamoru Narukawa

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Regulatory science for hernia mesh: Current status and future perspectives by Wenbo Liu, Yajie Xie, Yudong Zheng, Wei He, Kun Qiao, Haoye Meng

Subjects: “…Regulatory science…”
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Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science by Joan E. Adamo, Robert V. Bienvenu II, Felipe Dolz, Michael Liebman, Wendy Nilsen, Scott J. Steele

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The Current Status and Future Direction of Clinical Research in Japan From a Regulatory Perspective by Hideki Maeda

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Consumers’ perceptions of vape shops in Southern California: an analysis of online Yelp reviews by Steve Sussman, Robert Garcia, Tess Boley Cruz, Lourdes Baezconde-Garbanati, Mary Ann Pentz, Jennifer B Unger

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