Remote Working May Help Delay Retirement Of Senior US FDA Officials
CBER director Peter Marks notes efforts to bring in more staff to deal with ‘crushing’ workload; says there has been no political pressure for the center to approve COVID-19 booster shots.
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VRBPAC could help restore some confidence in any booster decision after White House moved ahead of FDA and CDC, but without hard outcomes data and no proven immune correlate of protection, support for Pfizer’s sBLA at the 17 September advisory committee meeting seems far from guaranteed.
Departures of Marion Gruber and Philip Krause may stem from White House and CDC actions related to the COVID-19 vaccines.
Director of the US FDA’s Office of New Drugs says there will be a greater focus on identifying the optimal dose before a drug candidate advances into Phase III trials, but the problem is not limited to oncology, the target of Project Optimus.