Alnylam’s Complete Response Is Classic Example Of FDA-Advisory Committee Disagreement

 
• By Sarah Karlin-Smith

The situation also is a perfect example of FDA doing what it says it does – paying more attention to the thinking behind advisory committee votes than the votes and vote totals themselves.

a wooded block with "yes" and a wooden block with "no". Finger points to "no" block.
When FDA disagrees with its advisory committees its more likely to result in a negative outcome for sponsors. • Source: Shutterstock

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