2 August 2021 - In response to continued criticism of FDA’s initiative to make promising new therapies available to seriously ill patients based on early clinical results, the agency’s leading cancer expert lashed out at the alarmists and urged continued support for this early access process. 

A comprehensive review of FDA’s accelerated approval program reveals that it has brought many important treatments to patients years before the completion of confirmatory studies, and that relatively few such products have been removed from the market post approval, asserted Richard Pazdur, director of FDA’s Oncology Center of Excellence.

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