Robert Califf got 89 votes in the Senate last time – but that’s also the least a Democratic nominee has ever gotten.
The nomination of Robert Califf to be commissioner of the US Food and Drug Administration sets off the confirmation process in the Senate: a committee hearing, a committee vote, and then a vote on the floor.
He’s been through this before, and cleared each hurdle, if not terribly quickly. With the Senate then in Republican hands...
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Suddenly the leadership changes at the US FDA’s Center for Biologics Evaluation & Research have begun to feel like a soap opera. That is not a recipe for regulatory predictability.
The once and current CBER director’s justification for his COVID-19 decision stands as a warning of the uncertainty sponsors, particularly those in the vaccine space, may now face at FDA.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.
The European Medicines Agency’s inaugural bilateral meeting with the Association of Clinical Research Organizations underscores ACRO’s commitment to advancing innovation and its presence in the EU clinical trials ecosystem.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Pfizer still has not submitted a supplemental biologics license application for the youngest population even though people familiar say it has dominated that market. Moderna says it can “step up” supply.
