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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With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.
The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.
FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.
FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.