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Therapeutic Innovation & Regulatory Science|May 11, 2023
Factors Affecting Success of New Drug Clinical TrialsEungdo Kim, Jaehoon Yang, Sungjin Park, et al.
Therapeutic Innovation & Regulatory Science|April 3, 2021
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research ForumGary J Noel, Robert M Nelson, Christina Bucci-Rechtweg, et al.
Therapeutic Innovation & Regulatory Science|August 9, 2020
Disagreements Between FDA and its Oncologic Drugs Advisory Committee (ODAC)Ariana Ayon Verduzco, Kwadwo Yeboah
Therapeutic Innovation & Regulatory Science|August 12, 2020
FDA's Benefit-Risk Framework for Human Drugs and Biologics: Role in Benefit-Risk Assessment and Analysis of Use for Drug ApprovalsLeila Lackey, Graham Thompson, Sara Eggers
Therapeutic Innovation & Regulatory Science|April 12, 2021
New Visualization Models of Designation Pathway and Group Categorization of Device-Drug and Device-Biologic Combination Products Classification in the United States: Analysis of FDA Capsular DecisionsNobuo Uemura, Hiroshi Kasanuki, Mitsuo Umezu
Therapeutic Innovation & Regulatory Science|July 15, 2020
Rebranding Gout: Could a Name Change for Gout Improve Adherence to Urate-Lowering Therapy?Matthew J Coleshill, Eindra Aung, Jane E Carland, et al.
Therapeutic Innovation & Regulatory Science|July 8, 2020
Bridging the Gap Between RCTs and RWE Through Endpoint SelectionRobert J LoCasale, Chris L Pashos, Ben Gutierrez, et al.
Therapeutic Innovation & Regulatory Science|April 22, 2021
Vaccines After an Emergency Use Authorization (EUA): Modern Evidence Generation ApproachesNévine Zariffa, Estelle Russek-Cohen
Therapeutic Innovation & Regulatory Science|April 5, 2023
From Meaningful Outcomes to Meaningful Change Thresholds: A Path to Progress for Establishing Digital EndpointsMarie Mc Carthy, Kate Burrows, Pip Griffiths, et al.
Therapeutic Innovation & Regulatory Science|April 18, 2023
Comparative Expedited Regulatory Programs of U.S Food & Drug Administration and Project Orbis PartnersLauren T Hotaki, Anu Shrestha, Monica P Bennett, et al.
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