The Trump transition team is considering Jim O'Neill, a Silicon Valley investment manager, to head US FDA, according to news reports. Previous comments from O'Neill – who has some HHS experience – suggest, he favors substantially reducing FDA's role in assessing product effectiveness. While some experts are highly skeptical about O'Neill, others suggest he could champion much-needed change at the agency.
A purported candidate to run FDA under the Trump administration would bring what some consider troubling views and experience to the commissioner post, but regulatory affairs stakeholders say Silicon Valley investor Jim O'Neill could be an interesting pick.
According to information first reported by Bloomberg, President-elect Donald Trump is considering replacing FDA Commissioner Robert Califf with...
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Medtech companies require expertise to navigate complex AI regulations and integrate AI in medical software while addressing regulatory challenges, claims expert AI consultant with medtech experience.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.
