US FDA Versus Its Own Precedents

The US FDA has shown astonishing flexibility in approving new drugs for neurodegenerative diseases based on efficacy evidence that falls well short of historical standards. Now the agency faces the delicate challenge of demonstrating that there are still some lines it will not cross.

face off
Who will win when FDA faces off against its past decisions? • Source: Shutterstock

The US Food & Drug Administration’ handling of BrainStorm Cell Therapeutics Inc.’s proposed ALS therapy NurOwn is, in part, an effort to draw some lines establishing the limits to regulatory flexibility in the face of significant unmet need.

For most of its history, the notion that FDA would base an approval on a failed pivotal trial would have...

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