1. Pink Sheet
  3. >>US FDA

Shutdown Deal Avoids Further US FDA Service Cuts, But Damage May Linger

 
• By Derrick Gingery

Employees are no doubt are excited to resume work and may have a dozen or more major NDAs pending, but agency morale may not recover quickly.

Early morning sky background, sunlight through white clouds and free birds flying away
President Trump has reached a deal with Democrats to temporarily reopen shuttered federal agencies until Feb. 15, so it should be blue skies ahead for FDA.

US FDA Commissioner Scott Gottlieb did not wait for President Trump to finish his speech announcing the deal to end the government shutdown to voice his excitement.

"I'm delighted by the announcement by [President Trump] of a deal to re-open the federal government," Gottlieb tweeted

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 US FDA

Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
• By Sarah Karlin-Smith

Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.

US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
• By Sue Sutter

Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.

Trump Administration Push For Dismissal, Transfer Of Mifepristone Case Leaves Overhang For Pharma

 
• By Sarah Karlin-Smith

The Trump Administration requested a dismissal or transfer of a lawsuit seeking to tighten the safety requirements for the abortion pill mifepristone on procedural grounds, which still leaves the administration's position on the case's merits unclear.

What MAHA Means For US FDA: Prevention Is Not What You Think

 
• By Michael McCaughan

US HHS Advisor Calley Means said new pathways for root-cause treatments are part of the HHS Secretary Robert F. Kennedy Jr.’s vision for the FDA. But what most biopharma companies consider preventative medicines are not what he has in mind, nor does he seem to see those companies as part of the solution.

More from Agency Leadership