US FDA Acting Commissioner Pick Could Underscore Trump Team’s IT Focus

Sara Brenner has been a key figure in the FDA’s diagnostics team, but her choice as acting FDA commissioner likely has more to do with her background with advanced technology and comfort level with the tech-focused side of the Trump transition team.

Doctor Working With Futuristic Floating Screen
EU to embrace digital health opportunities as catalyst for future advances in medtech (Shutterstock)

The selection of Sara Brenner as US Food and Drug Administration acting commissioner strongly suggests that the Trump Administration will focus heavily on the impact of new technology on regulatory agencies.

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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.

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.

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Decentralized Trials: FDA Final Guidance Eliminates Need For Local Provider Activity Tracking

 
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Draft recommendation for investigators to maintain a task log of activities that local health care providers perform was removed from final guidance on decentralized clinical trials. Other changes include more detail on US FDA oversight and what HCPs can and cannot do in such studies.

Pharma Warming Up To Benefits Of Australia’s Teletrials Initiative

 
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The Australian teletrials program has surpassed expectations at its mid-way point and is being used by drug and device sponsors looking to enhance trial participant recruitment and retention by enabling access to rural, regional and remote areas.

EFPIA Calls For Active Inclusion Of Pharma Industry In Roll Out Of European Health Data Space

 

The implementation phase of the European Health Data Space is an opportunity to address “critical aspects” of the new regulation that require clarification, says pharmaceutical industry federation EFPIA.