US FDA's Avastin decision: into the minds of regulators
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration on 18 November laid out its big decision on Avastin's breast cancer indication in a 69-page ruling1. The document had two somewhat distinct sections: known-knowns and known-unknowns – to borrow the peculiar vernacular of Donald Rumsfeld, former US defence secretary.
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