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US FDA And The ‘Move Fast And Break Things’ Government

The Trump transition so far has all the hallmarks of the tech industry’s favorite management slogan, but that might not work well for biopharma companies if the FDA is one of the agencies that gets broken.

HHS Nominee Kennedy’s Behind-The-Scenes Vaccine Reassurances Win Senate Swing Vote

Outreach by Kennedy and the Trump Administration appears to have quelled Sen. Cassidy’s fears about oversight of vaccine regulations and safety monitoring.

HHS Nominee Kennedy’s Behind-The-Scenes Vaccine Reassurances Win Senate Swing Vote

Outreach by Kennedy and the Trump Administration appears to have quelled Sen. Cassidy’s fears about oversight of vaccine regulations and safety monitoring.

Kennedy As HHS Secretary Has Potential To Boost US FDA’s Regard For Supplement Industry

“We've heard perhaps some kind of support for non-drug approaches to addressing a range of conditions,” says food and drug regulation attorney Jessica O’Connell. “For the first time in the nearly 80 years of HHS, we will have a secretary who actually sees our commodity is valuable and not just some nuisance they have to deal with,” says NPA CEO Daneil Fabricant.

US FDA Senior Staff Return To Office In February, Next Steps for Schedule F Reclassification

New details are emerging about how the administration will implement some of President Trump’s workforce shift back to mostly in-office work.

Who’s Running The US FDA? Interim Team May Not Have Assumed Control

White House expected to name Sara Brenner, chief medical officer for in vitro diagnostics at CDRH and a veteran of first Trump administration, as acting commissioner, but lack of a formal announcement is creating uncertainty. New executive orders on telework and the senior executive service also could impact agency staff.

Trump’s US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say

Former FDA commissioners Mark McClellan and Scott Gottlieb, former acting commissioner Janet Woodcock and current commissioner Robert Califf offered advice on successfully implementing reforms and preventing a mass exodus of FDA employees as inklings emerge that the Trump team is already engaged on this front.

FTC Proposed Rule Change Targeting Direct Sellers Gets Direct Challenge From Incoming GOP Majority

FTC seeks comment on three proposals to “strengthen the agency’s tools to curb deceptive earnings claims in industries where they are pervasive: multi-level marketing programs and money-making opportunities.” However, Republican members say they’ll reconsider the proposals as a majority after Trump takes office.

Can US FDA Dodge DOGE? Return To Office Mandate May Be Biggest Hit

The incoming Trump Administration’s “Department Of Government Efficiency” has big plans for sweeping cuts to the federal bureaucracy and regulation. The US FDA likely will feel some effects, but could avoid the most damaging mandates.

Cautious Optimism For US FDA Commissioner Nominee’s Self-Professed Data Driven Approach

Martin Makary prides himself on following the data, but some health policy experts said his positions sometimes stray from or distort the evidence, which could create trust issues.