Tag: clinical trial design

FDA Draft Guidance: Adaptive Designs for Clinical Trials of Drugs and Biologics

On November 29, the Food and Drug Administration (FDA) issued a final guidance for industry entitled, “Adaptive Designs for Clinical Trials of Drugs and Biologics.” Adaptive design clinical trials allow for prospectively planned modifications to one or more aspects of the design based on accumulating data from subjects in the trial. The guidance provides information to sponsors […]

Regulatory Education for Industry (REdI): Clinical Investigator Training Course

November 12-14, 2019 The Hotel at the University of Maryland, College Park, MD The course fee is $500 and includes attendance to program sessions, coursebook with all speaker slides, breakfast on November 12-14, and daily refreshment breaks. A room block is available for the rate of $179/night This course provides a study of clinical trial […]

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