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Re: None

Thursday, 11/30/2017 10:42:08 AM

Thursday, November 30, 2017 10:42:08 AM

Post# of 48316

Gottlieb: FDA working on a proposal for cancer drugs already approved for one indication where approval for a suppl. app., for 2nd indication can sometimes rely on a more targeted data set, like a single-arm study. Guidance coming to clarify circumstances when appropriate.