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    FDA’s Oncology Clinical Trial Makeover

    Recent communication by FDA affirming its support for modernized oncology clinical trial conduct, manifested in four guidance documents addressing adolescents, conduct of First-in-Human (FIH) expansion cohorts, the use of placebo/maintenance of the study blind and master protocols. This article provides an overview of new FDA guidances related to oncology drug development and a review of pilot programs aiding faster access to new, innovative treatments without increasing r...