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Therapeutic Innovation & Regulatory Science|May 16, 2018
Risk-Based Data Monitoring: Quality Control in Central Nervous System (CNS) Clinical TrialsCynthia McNamara, Nina Engelhardt, William Potter, et al.Therapeutic Innovation & Regulatory Science|June 30, 2018
Assessing Treatment Effects That Capture Disease Burden in Serious Chronic DiseasesMouna Akacha, Bruce Binkowitz, Brian Claggett, et al.Therapeutic Innovation & Regulatory Science|July 7, 2018
US Medical Information Websites Benchmarking: How Is the Industry Fairing in Usability?Etienne Paquette-Lemieux, Steven Hays, Rania GaspoTherapeutic Innovation & Regulatory Science|June 8, 2018
Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in ChinaJun Wang, Gang Wang, Min Li, et al.Therapeutic Innovation & Regulatory Science|July 4, 2017
Adaptive Clinical Trials: Overview of Early-Phase Designs and ChallengesOlga Marchenko, Valerii Fedorov, J Jack Lee, et al.Therapeutic Innovation & Regulatory Science|June 19, 2018
Practical Issues in Clinical Inspection ProcessFuyu Song, Xue Qian, Jianming Li, et al.Therapeutic Innovation & Regulatory Science|November 25, 2014
Investigators' Experience With Expedited Safety Reports Prior to the FDA's Final IND Safety Reporting RuleJudith M Kramer, David Vock, Howard E Greenberg, et al.Therapeutic Innovation & Regulatory Science|September 2, 2020
A Multifaceted Perspective of Pharmaceutical Innovation: A Consideration of the Regulatory RoleMark Robberson, Christopher D BrederTherapeutic Innovation & Regulatory Science|November 24, 2020
New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product LabelsKatrine Schultz-Knudsen, Ugne Sabaliauskaite, Johan Hellsten, et al.Therapeutic Innovation & Regulatory Science|November 3, 2020
phactMI™ Benchmarking Survey: Analysis of 27 Medical Information Departments Responses to Inquiries from Health Care Decision MakersAnnaMaria D'Ascoli, Andrew Gazo, Sue Yueh, et al.Pageof 165