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

 
• By Michael McCaughan

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.

FDA entrance sign 2016

The 21st Century Cures Act includes a lot of FDA-related reform provisions, but it is not a transformative piece of legislation for the agency.

The bipartisan encomiums about a new era of innovation and the howls of complaint about lowering standards from a handful of dissenters notwithstanding, there is nothing in the Cures law that will have an immediate impact on drug development. And, in a climate where FDA is generally getting high marks for supporting innovation, that is probably as it should be

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More from Agency Leadership

Makary’s Reorganization Decision A Turning Point For US FDA?

 
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