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FDA Drug Approval and the Ethics of Desperation. [PDF]
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Factors influencing FDA drug approval decisions beyond clinical trial evidence: a scoping review. [PDF]
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Implications of Evolving Disease Classification for Drug Approval in Juvenile Idiopathic Arthritis. [PDF]
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Pediatr Res, 2023 Coppes MJ, Jackson C, Connor EM.
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Facilitating Expedited Drug Approval-the Past, Present, and Future of Clinical Trials for Pediatric Rheumatic Disease. [PDF]
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Pharmacol Res Perspect, 2023 Saito R, Miyazaki S.
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DrugReasoner: Interpretable drug approval prediction with a reasoning-augmented language model. [PDF]
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An open science pathway for drug marketing authorization-Registered drug approval. [PDF]
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