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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Upcoming retirement of Janet Woodcock will mean loss of one of agency's FDA’s most experienced and influential drug regulators. However, CDER still has plenty of long-tenured staff peppered across all its key functions.
The upcoming retirement of Janet Woodcock will mean the loss of one of the US FDA’s most experienced and influential drug regulators. However, the drug center still has plenty of long-tenured staff peppered across all of its key functions.
With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior leadership.