Life After Woodcock: US FDA Drug Center’s Leadership Transition
The elevation of the US FDA’s top drug regulator, Janet Woodcock, to oversee COVID-19 response efforts is being framed a temporary step as part of the crisis response. But it is also a try-out for the most significant leadership transition in drug regulation in the US in a generation.
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CBER Director Marks will no longer have to recuse himself from COVID-19 product reviews, a move seen as resoundingly positive by former senior FDA leaders. CDER Director Woodcock will now be free to focus solely on COVID-19 and bring her unique depth of agency experience to the Trump Administration's effort to speed development of vaccines, therapeutics and diagnostics for coronavirus.
Senate pandemic economic relief legislation legislation would reform monograph drug program and allow purchases of OTC drugs with pre-tax health savings accounts. But lingering disagreements between Democrats and Republicans blocked the Senate's passage of the bill on 25 March.
Patrizia Cavazzoni, Janet Woodcock's new #2, has a background similar to Richard Moscicki, CDER's previous deputy director for operations.