A leadership change at the US Food and Drug Administration’s medical device center is intended to provide a relatively smooth transition, but also raises questions about the potential for more disruptive changes in the agency’s leadership team in the coming year.
US FDA And The Election: Watch The Center Directors
A change in leadership of the US FDA device center is taking place with an eye towards stability in the longer term, but the upcoming elections could lead to more disruptive personnel changes.
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The FDA will stay open, but its rare disease priority review voucher program will wind down after not being renewed on 20 December. PBM reform and other industry priorities also were nixed at the last minute in an effort to avoid a government shutdown.
Robert Temple, the US FDA’s most experienced drug regulator, is currently serving an emeritus role at the agency. The immediate impact of his departure will be mostly symbolic, but still unsettling.
Namandje Bumpus' departure means there is no obvious, internal candidate to serve as acting commissioner when President-elect Donald Trump takes office in January and the Senate works to confirm a new leader.
Whether the FDA will seek withdrawal of the anticoagulant-reversal agent or request additional confirmatory data is unclear.
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A safety signal may be platform or even Moderna-specific, the Vaccines and Related Biological Products Advisory Committee said.
Some pharma industry CEOs appear to have done well in their meeting with President-elect Donald Trump and his health care team.
Former Sen. Richard Burr suggested to the Pink Sheet that Trump’s HHS leadership picks will have less ability to enact their agendas than people expect.