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FDA’s Remarkable ALS Drug Approval: Call It The 'Hendeles Standard'

Executive Summary

US FDA’s approval of Mitsubishi's Radicava (edaravone) is yet another demonstration of the agency’s flexibility for drugs to treat rare diseases – and pre-emptive action to fend off “Right to Try” laws. It is also a belated endorsement of one of the stranger votes by an FDA advisory committee member almost a decade ago.

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