New CDER No. 2 May Impact FDA's Safety Monitoring Aspirations

Patrizia Cavazzoni, CDER's new deputy director for operations, has safety surveillance background and wants to see FDA continue to grow its capabilities.

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Patrizia Cavazzoni's safety surveillance expertise may come in handy early in her tenure as the Center for Drug Evaluation and Research's deputy director of operations given the US FDA's desire to continue expanding the use of its Sentinel system.

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FDA Layoffs: US Likely To Lose Its First Approver Advantage

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.

Updated: US FDA Commissioner Makary Was Sworn In, Knew Of Plan to Push Out Marks, Sources Say

 

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.

Peter Marks Resigns From US FDA, Warns Kennedy Does Not Want Truth On Vaccines

 

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."

Oncology Center Of Excellence Deputy Directors Kluetz, Theoret Join US FDA Exodus

 

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.

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Oncology Center Of Excellence Deputy Directors Kluetz, Theoret Join US FDA Exodus

 

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.

Power Play: US FDA Likely Losing More Than Just Staff With Restructured Health Department

 

About 3,500 full-time FDA employees are expected to be laid off as part of a restructuring of the Health and Human Services Department and experts questioned whether the cuts could be implemented without harming FDA’s core mission.

Government Pulls ‘For Sale’ Signs From US FDA’s White Oak Campus

 
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The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.