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Therapeutic Innovation & Regulatory Science|June 28, 2025
Evaluation of Optimal Cut-Offs and Dichotomous Combinations for Two Biomarkers to Improve Patient SelectionGina D'Angelo, Di Ran, Binbing YuTherapeutic Innovation & Regulatory Science|June 17, 2025
The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative SurveyKieran Connole, Olivia McDermottTherapeutic Innovation & Regulatory Science|June 10, 2025
Electronic patient-reported outcome assessments: evaluating patient preference for the number of items per screenJennifer Lord-Bessen, Danielle Rodriguez, Karin S Coyne, et al.Therapeutic Innovation & Regulatory Science|June 8, 2025
Trends in the Burden for Patients Participating in Industry-Funded Clinical TrialsAbigail Dirks, Emily Botto, Zachary Smith, et al.Therapeutic Innovation & Regulatory Science|April 8, 2025
Development of Composite Index in Psychiatry Clinical TrialHaiqi Zhang, Shein-Chung ChowTherapeutic Innovation & Regulatory Science|March 19, 2025
Increasing the Utility of Real-World Data to Inform Public Health Decision Making Through a US-based Private-Public Partnership: 10 Lessons Learned from a Principled Approach to Rapid Pandemic RWE GenerationNicolle M Gatto, Elizabeth M Garry, Melanie Wang, et al.Therapeutic Innovation & Regulatory Science|May 5, 2025
A Comprehensive Retrospective Analysis of Trends and Strategic Implications of 505(b)(2) Approvals (2019-2023)Ramesh Joga, Kailas Vijay Gadekar, Kajal Gandhi, et al.Therapeutic Innovation & Regulatory Science|March 12, 2026
An NCI Micro-credentialing Model for Onboarding and Training Clinical Research Professionals in a Lean Fiscal EnvironmentBarbara Tafuto, Belinda Zhang, Kathleen Black, et al.Therapeutic Innovation & Regulatory Science|March 5, 2026
Applications and Challenges of Artificial Intelligence and Big Data in Drug RegulationZhao Liu, Yang Zheng, Jun Fang, et al.Therapeutic Innovation & Regulatory Science|March 7, 2026
Challenges and Potential Solutions to Advance Global Cancer Drug DevelopmentAxel Glasmacher, Kim Lyerly, Birgit Wolf, et al.Pageof 165