After US FDA Diversity Action Plan, Sex Differences Webpages Restored Will Others Follow?

A federal judge granted Doctors for America’s motion for a temporary restraining order directing the FDA and CDC to restore information removed from the agencies’ websites to comply with a presidential executive order targeting “gender ideology extremism.”

Wayback Machine
The sudden removal of information resources from federal agency websites is not excused by their availability on the Wayback Machine, a judge said. (Shutterstock)

A court order directing the US Food and Drug Administration to restore a webpage for the clinical trial diversity action plan guidance could lead to reinstatement of other information removed from the agency’s website in recent weeks.

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Mifepristone Filing Supports 2023 US FDA Actions, But Experts Caution Against Overanalyzing

 

Filing in the Whole Women’s Health mifepristone case defends the FDA’s 2023 decision on the abortion pill safety program, but experts warn it does not necessarily signal the Trump Administration position in other mifepristone cases attempting to restrict medication abortion access.

Supreme Court May Be Next After Federal Circuit Refuses To Rehear Teva Inhaler Patents Case

 

Teva was forced to delist its ProAir HFA inhaler patents from the FDA’s Orange Book by mid-March after the Federal Circuit denied its petition for en banc rehearing. Will the Supreme Court listen?

HHS Wants 340B Rebate Debate Out Of Courts, Returned To Government

 
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An HHS legal brief argues company lawsuits seeking immediate clearance to use rebates in 340B are premature and that the department has merely used a ‘measured approach’ in weighing the possibility. Past experience suggests otherwise, a pricing expert said.

Kennedy’s Pullback of Public Comment Policy Make May Rules Vulnerable to Lawsuits

 

The Health and Human Services Department's decision to eliminate the Richardson Waiver may be a blow for transparency, but will not completely eliminate scrutiny of regulations, experts said.

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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.

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

Can New US FDA Commissioner Makary Calm Agency During Turbulent Times?

 

Stakeholders are pleading for newly confirmed FDA Commissioner Martin Makary to stand up for the agency's high scientific standards and staff as he begins his term.