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Therapeutic Innovation & Regulatory Science|March 5, 2026
Systematic Review of Patient Focused Drug Development Meeting Reports for Conditions Affecting NeurodevelopmentCristan Farmer, Victoria Kim, Tanvi Das, et al.
Therapeutic Innovation & Regulatory Science|June 9, 2026
Identification of Chronic Stress-Related Biomarkers for Potential Diagnosis and Treatment of Osteoporosis: An Integrated Multi-omic and Clinical Data AnalysisHuang Fang, Rui He
Therapeutic Innovation & Regulatory Science|April 26, 2026
Development of a Novel Risk Assessment Scale to Improve the Consistency and Reliability of Risk-Based Approaches in Clinical TrialsTakahiro Kuwahara, Ryota Kidena, Naoki Kato, et al.
Therapeutic Innovation & Regulatory Science|April 26, 2026
Training Needs Assessment and Capacity Building of Clinical Trial Assessors and Ethical Reviewers to Strengthen Regulatory Review in TanzaniaKissa W Mwamwitwa, Castory G Munishi, Paul Malaba Makoye, et al.
Therapeutic Innovation & Regulatory Science|April 30, 2026
Analyses of U.S. FDA GCP Assessments and Recommendations for Marketing Applications, 2015-2024Courtney McGuire, Michelle Foringer, David Burrow, et al.
Therapeutic Innovation & Regulatory Science|June 15, 2026
Benchmark Survey on Content Development and Key Performance Indicators: A phactMI Benchmarking Survey UpdateRobert Tamburri, Mary K Sendi, Anja Glaetzer, et al.
Therapeutic Innovation & Regulatory Science|June 14, 2026
Cardiovascular Toxicity of Monoclonal Antibodies Approved for Multiple Myeloma: Evidence Based on FAERS DatabaseTing Liang, Junfeng Li, Cong Xu
Therapeutic Innovation & Regulatory Science|June 30, 2023
Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and DeploymentLidia Betcheva, Jennifer Y Kim, Feryal Erhun, et al.
Therapeutic Innovation & Regulatory Science|June 30, 2023
Implementation of Regulation (EU) No 536/2014 as a Non-commercial Sponsor: An Internal Survey and a Descriptive Analysis of TimelinesJelle Stans, Sara Verbandt, Stéphanie Kromar, et al.
Therapeutic Innovation & Regulatory Science|June 30, 2023
Evaluation of FDA Labeling Changes Related to PREA Safety-WaiversJason Krastein, Denise Pica-Branco, Matthew A Bacho, et al.
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