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Therapeutic Innovation & Regulatory Science|March 19, 2026
CARE Framework for Inclusive Clinical Studies: An Evidence-Based Approach for and Measurement of Recruitment and Retention of Black Women in Breast Cancer ResearchShreya N Sarathy, Leslie Sam, Melva T CovingtonTherapeutic Innovation & Regulatory Science|March 19, 2026
Advancing Platform Trials in Early Oncology by Using MATS and EXNEX in Randomized Controlled TrialsZhe Chen, Gu Mi, Ji LinTherapeutic Innovation & Regulatory Science|April 21, 2024
Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in JapanMasatoshi Tanigawa, Mei Kohama, Kaori Hirata, et al.Therapeutic Innovation & Regulatory Science|April 17, 2024
Pathway for Development and Validation of Multi-domain Endpoints for Amyloid Light Chain (AL) AmyloidosisJames Signorovitch, Jialu Zhang, David Brown, et al.Therapeutic Innovation & Regulatory Science|April 15, 2024
The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory HistoryJonathan H Sussman, Ahmed Albayar, Anissa Saylany, et al.Therapeutic Innovation & Regulatory Science|May 8, 2024
Regulatory Framework for Drug-Device Combination Products in the United States, Europe, and KoreaJoo Hee Kim, Sera Kwon, Ju Eun Seol, et al.Therapeutic Innovation & Regulatory Science|April 29, 2024
The Effect of Antihyperglycemic Medications on COVID-19: A Meta-analysis and Systematic Review from Observational StudiesZhi-Hui Song, Qiao-Ming Huang, Shan-Shan Xu, et al.Therapeutic Innovation & Regulatory Science|April 10, 2024
Reflections on the Saudi FDA Regulatory Experience with Smart GxP InspectionsAli M Alhomaidan, Nawaf G Al-Murikhi, Morae A Al-Qarni, et al.Therapeutic Innovation & Regulatory Science|September 8, 2023
Comparison of the Latin America Regulation Landscape and International Reference Health Authorities to Hasten Drug Registration and Clinical Research ApplicationsUrimara Argotti, Lada Leyens, Carlos Lisbona, et al.Therapeutic Innovation & Regulatory Science|March 22, 2026
Use of Information Technology to Mitigate Protocol Deviations in Clinical Research: A Quality Improvement ProjectKathryn E Hall, Jean M BernhardtPageof 165