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Woodcock, Marks Recusals From COVID-19 Product Reviews 'Protect FDA's Reputation'

 
• By Brenda Sandburg

FDA experts say there is deep bench in CDER and CBER to tackle review questions while directors Janet Woodcock and Peter Marks help lead Operation Warp Speed; regulatory community is 'reassured' they will oversee advancement of COVID-19 therapeutics and vaccines.

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Top FDA officials recuse themsleves from COVID-19 product review decisions

Companies developing COVID-19 related products will no longer be able to turn to Janet Woodcock and Peter Marks – the respective directors of the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research – to get their input on review matters. But FDA experts say this will not have a significant impact on reviews and is the right move to avoid the appearance of impropriety.

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