5 ms·
To almost all of the questions, 90%+ of the advisory board voted no/uncertain, yet FDA completely overrode/ignored their advice... I would understand if it was
by ehsankia 5y ago
To almost all of the questions, 90%+ of the advisory board voted no/uncertain, yet FDA completely overrode/ignored their advice... I would understand if it was 50/50, but what's the point of getting an independent board if all of them tell you no and you still say yes?
> In his resignation letter, Kesselheim said the agency’s decision on Biogen “was probably the worst drug approval decision in recent U.S. history.”