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Latest From Zogenix, Inc.
Confirmation hearing comment suggests FDA Commissioner nominee Robert Califf thinks an overwhelming advisory committee vote should give agency officials pause.
No one thinks it is a good idea for the US FDA Commissioner or some other higher up political actor to decide when and if to approve new drug applications. But it might not be so bad if the scientific staff at FDA paid a bit more attention to ‘political’ issues before making some decisions.
Robert Califf offers some interesting clues as to how he’d handle top drug policy issues in his Senate confirmation hearing.
President Biden’s pick for FDA commissioner should remember many of the hot-button issues that he would face upon confirmation, such as drug pricing and approval standards.
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