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Therapeutic Innovation & Regulatory Science|July 3, 2025
"Appropriateness" of Clinical Data Under Regulation (EU) 2017/745- A Case Study and SurveyElisabeth Oltmanns, Michael D'Agosto, Folker SpitzenbergerTherapeutic Innovation & Regulatory Science|September 24, 2025
A Preliminary Study Introducing Electronic Patient-Reported Outcome (ePRO) Using Bring Your Own Device (BYOD) in Post-marketing Surveillance in JapanNaomi Sugimoto, Mika Morimasa, Hidetoshi Misawa, et al.Therapeutic Innovation & Regulatory Science|October 10, 2025
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016-2023)Yoseok Park, Kyenghee KwonTherapeutic Innovation & Regulatory Science|May 13, 2025
Considerations and Approaches to Establishing Estimates of Meaningful Change for Digital Endpoints as Drug Development ToolsMarie Mc Carthy, Joseph C Cappelleri, Bill Byrom, et al.Therapeutic Innovation & Regulatory Science|May 20, 2025
Recent Updates to the Declaration of Helsinki: A View from the U.S. Food and Drug AdministrationRobert M Califf, Ann Meeker-O'Connell, Shari Targum, et al.Therapeutic Innovation & Regulatory Science|July 25, 2025
Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting ApproachNoraisyah Mohd Sani, Siti Hidayah Kasbon, Kian Yee Yap, et al.Therapeutic Innovation & Regulatory Science|May 29, 2025
Overview of Orphan Medicines in European Union: An Analysis of Regulatory and Technical-Scientific AspectsGreta Santi Laurini, Victoria Nikitina, Massimiliano Broccoli, et al.Therapeutic Innovation & Regulatory Science|June 3, 2025
Practice of Cryopreservation of Cellular Starting Materials from the Asia-Pacific Region: An Industrial PerspectiveYun Hsiang Chang, Yuma Fujimori, Cheng Chieh Chen, et al.Therapeutic Innovation & Regulatory Science|October 29, 2025
Improving Informed Consent for English and Spanish Speakers in Clinical TrialsSusana Peinado, Jessica E Thompson, Leo Plouffe, et al.Therapeutic Innovation & Regulatory Science|October 19, 2025
Estimating Treatment Effect for Target Population in Psychiatric Clinical Trials Using Placebo Lead-in DesignZhao YangPageof 165