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Presented by CVS Health
On Tap J&J files for emergency use setting the stage for a third option. FDA limits plasma to early use after new data.
It’s Friday, welcome back to Prescription Pulse. Let s hear it for beer-reviewed research, up there with vaccine sh s and pubic health. As always, send tips (and, I guess, typos) to Sarah Owermohle at [email protected] or @owermohle. Loop in David Lim ([email protected] or @davidalim) and Brianna Ehley ([email protected] or @briannaehley)
Dive Brief:
Janet Woodcock, head of the Food and Drug Administration s drug review division, will serve as acting commissioner of the agency while President Joseph Biden decides on a permanent chief. She is one of several current and former high-ranking FDA officials believed to be under consideration for the permanent job.
Detailed last year to the former Trump administration s coronavirus response team, Operation Warp Speed, Woodcock will recuse herself from FDA decisions involving certain COVID-19 drugs that she assisted in development. That recusal will not apply to vaccines or diagnostics.
Woodcock will have a full plate, with as many as three coronavirus vaccines potentially needing review in coming months and two others that may convert to full agency approval after already gaining emergency authorization. Meanwhile, the FDA will need to work on a backlog of non-COVID drug approval decisions that have been put on hold because inspectors can t travel to some manufacturing f