FDA Faces Succession Questions As Hahn’s Departure Nears
Plan specifying the acting head of the US FDA until new commissioner is confirmed references senior positions that no longer exist.
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The agency has been prepping Woodcock for the temporary task but what will happen to her role on Operation Warp Speed remains unclear. The move should give the incoming Biden team cushion to confirm a permanent leader, of whom a top contender is former senior FDA staffer Joshua Sharfstein.
J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.
Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval
After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.