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Oncology In 21st Century Cures: Heading Toward A Two-FDA Solution?

Executive Summary

The 21st Century Cures Act regulatory reform provisions amount to a lot of little things: tweaks to encourage ongoing activities rather than bold departures at a time when the overall regulatory climate is good for innovators. But the law could also be the start of something bigger – a more formal division within the US FDA between oncology and everything else.

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