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Gottlieb Uses ASCO Platform To Unveil Two Pilot Programs To Speed Drug Review

 
• By Jessica Merrill

US FDA commissioner outlines plans to allow partial submissions as soon as database locks and to create joint sponsor-agency review documents.

US FDA Commissioner Scott Gottlieb used the opening session of the American Society of Oncology annual meeting in Chicago on June 2 as an opportunity to deliver a message that the agency is laser-focused on improving the drug review process to speed new innovations to market.

"There are critics who think that we should hold drugs back from the market, and demand more pre-market studies emphasizing overall survival endpoints before we consider approving new treatments," he...

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