No one individual is responsible for all aspects of an organization as large and diverse as the Center for Drug Evaluation and Research in the US Food and Drug Administration.
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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Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.
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FDA Commissioner Martin Makary was sworn in Friday and knew of the plan that ultimately lead to CBER director Peter Marks' resignation on 28 March.
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In his resignation letter, the CBER director said he was willing to work with HHS Secretary Robert F. Kennedy Jr. to address concerns about vaccine safety, but "it has become clear that truth and transparency are not desired by the secretary."
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The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.