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Therapeutic Innovation & Regulatory Science|September 6, 2024
Adopting a Framework for Rapid Real-World Data Analyses in Safety Signal AssessmentLu Wang, Negar Golchin, Stephanie von Klot, et al.Therapeutic Innovation & Regulatory Science|September 6, 2024
Delta Inflation, Optimism Bias, and Uncertainty in Clinical TrialsCharles C Liu, Peiwen Wu, Ron Xiaolong YuTherapeutic Innovation & Regulatory Science|August 30, 2024
Current Application of the Medical Device Single Audit Program (MDSAP) as a Global Regulatory Reliance Framework for the Inspection of Medical DevicesKenichi Ishibashi, Masuo Kondoh, Tetsuya KusakabeTherapeutic Innovation & Regulatory Science|September 2, 2024
Tips for Accelerating BOIN DesignMasahiro Kojima, Wu Wende, Henry ZhaoTherapeutic Innovation & Regulatory Science|August 23, 2024
A Global Industry Survey on Post-Approval Change Management and Use of RelianceAndrew Deavin, Aliyah Hossain, Isabelle Colmagne-Poulard, et al.Therapeutic Innovation & Regulatory Science|November 17, 2024
Testing the Feasibility of a Digital Point of Care Solution for the Trusted Near Real-Time Bidirectional Exchange of Novel and Informative Adverse Event InformationGreg Powell, Vijay Kara, Daniel Naranjo, et al.Therapeutic Innovation & Regulatory Science|August 4, 2024
Capacity Assessment of the National Medicines Regulatory Authority in a Low -Income CountryFawzi Thomas, Onome T Abiri, Thomas A Conteh, et al.Therapeutic Innovation & Regulatory Science|June 24, 2024
Qualitative Analysis of Inquiries Received by FDA Regarding Conduct of Clinical Trials during the Covid-19 Public Health EmergencyMarijo Kambere, Hong Vu, Dana Kappel, et al.Therapeutic Innovation & Regulatory Science|July 2, 2024
Efficiency of eSource Direct Data Capture in Investigator-Initiated Clinical Trials in OncologyHiroko Yaegashi, Yukikazu Hayashi, Makoto Takeda, et al.Therapeutic Innovation & Regulatory Science|June 22, 2024
Use of Seamless Study Designs in Oncology Clinical Development- A Survey Conducted by IDSWG Oncology Sub-teamYingwen Dong, Gautier Paux, Kristine Broglio, et al.Pageof 165