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Therapeutic Innovation & Regulatory Science|April 4, 2023
Review of the Food and Drug Administration's Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Mid-Cycle CommunicationsRichard D Hoffman, Scott D Beattie, Jennifer Riddle Camp, et al.Therapeutic Innovation & Regulatory Science|June 20, 2020
When Context Is Hard to Come By: External Comparators and How to Use ThemChristina Mack, Jennifer Christian, Emma Brinkley, et al.Therapeutic Innovation & Regulatory Science|February 20, 2020
Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) GuidelinesBohdana Ratitch, Niti Goel, Craig Mallinckrodt, et al.Therapeutic Innovation & Regulatory Science|September 18, 2018
Generational Value Differences Affecting Public Perceptions of and Willingness to Participate in Clinical TrialsApril M Nelson, Irwin G Martin, Kenneth A GetzTherapeutic Innovation & Regulatory Science|June 18, 2026
Trends and Regulatory Insights on Illicit Pharmaceutical and Cosmetic Imports: Evidence from Malaysia's Operation Pangea 2020-2023Shing Chyi Loo, Alvina Li Wen Kueh, Alyia Farhana MuhadzirTherapeutic Innovation & Regulatory Science|June 18, 2026
Expertise of European Clinical Trial Units in Conducting and Managing Cross-Border Pediatric Clinical Trials for Rare DiseasesBegonya Nafria, Segolene Gaillard, Martine Dehlinger-Kremer, et al.Therapeutic Innovation & Regulatory Science|September 21, 2018
Adaptive Clinical Trials: Overview of Phase III Designs and ChallengesJeff Maca, Vladimir Dragalin, Paul GalloTherapeutic Innovation & Regulatory Science|July 2, 2026
Understanding the Added Value of Action Limits for QTL MonitoringNathalie van Borrendam, Annett Keller, Leon Els, et al.Therapeutic Innovation & Regulatory Science|June 27, 2026
Utilization of Clinical Evaluation Reports in Japan's Medical Device Approvals: Insights from Review Data on Approved DevicesKoji Yamada, Daisuke Obata, Jun Matsubayashi, et al.Therapeutic Innovation & Regulatory Science|July 23, 2026
Schizophrenia Impacts and Treatment Priorities: Results of An Externally-Led Patient-Focused Drug Development Meeting SurveyIlse S Peterson, Ramaa Chitale, Theresa Frangiosa, et al.Pageof 165