FDA talking about how Cures Act compliance is goin

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Gottlieb told the committee that the agency is working on a proposal whereby cancer treatments already approved for one indication might be able to win approval for a second indication based on a supplemental application that relies on “a more targeted data set, like a single-arm study. We intend to issue guidance further clarifying the circumstances in which this is appropriate.

“This may be suitable, for example, when there’s a clear and outsized treatment effect, and the second indication concerns the same disease as the first one, but for a new setting. For example, a targeted drug approved for a third-line use that shows benefit in a second-line indication,” Gottlieb added.

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