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FDA Week - 12/01/2017

Gottlieb Outlines Steps For Streamlining Cancer Drug Approvals

November 30, 2017
FDA is developing a policy by which the agency can approve subsequent indications of cancer drugs with less rigorous follow-up trials, FDA Commissioner Scott Gottlieb announced Thursday (Nov. 30). The agency will also provide more guidance on how FDA believes it can approve treatments based on intermediate clinical endpoints, which one expert explained may be significant when exploratory or so-called go-no-go trials show a significant improvement and time is of the essence to get the drugs approved. Both moves by...


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