1. Pink Sheet
  2. >>Legal & IP
  3. >>Litigation

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

 
• By Sue Sutter

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.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Litigation

Lilly Targets Sale Of Repackaged, Redosed Zepbound, Mounjaro In Lawsuit

 
• By Cathy Kelly

Eli Lilly is seeking an injunction barring a weight loss clinic from dispensing modified versions of its GLP-1 products.

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

 
• By Sarah Karlin-Smith

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

 
• By Urtė Fultinavičiūtė

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

 
• By Cathy Kelly

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.

More from Agency Leadership

US FDA Rare Disease Innovation Hub’s Goals Align With Trump, Leader Says

 
• By Sue Sutter

The hub’s goals of efficiency, centralization and coordination fit with the Trump Administration’s current focus for the FDA, Amy Comstock Rick, director of strategic coalitions, told the Biopharma Congress.

Trump’s US FDA Takeover Similar To Flat Earth Proponents Running NASA, Woodcock Says

 
• By Sue Sutter

The former principal deputy commissioner said the “decapitation” of senior leadership will make resolving internal disputes more difficult, which will slow application reviews. Woodcock also called the FDA layoffs a slow-moving catastrophe.

US FDA Center Directors Are Political Now

 
• By Michael McCaughan

The forced departure of CBER Director Peter Marks is a milestone event for the agency, as center directors now are likely to be treated as political positions subject to change with each new administration.