What If FDA Actually Shuts Down?

As “funding lapse” for US FDA continues, agency continues to triage programs to maximize its ability to protect public health and safety. Is that laudable approach actually counterproductive? 

a finger is pushing the power button to wake laptop up or shutdown it - Image

It says something about the recent pattern of partisan disagreements in Washington, D.C. that FDA has developed a relatively robust playbook for how to handle a lapse in appropriations.

The first step is for everyone to report to work and execute an orderly shutdown. Managers write out plans for...

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

More from US FDA

HHS Secretary Favors Regenerative Medicine Over Traditional Pharma: Blessing And Curse?

 

Cell and gene therapy developers may not have to contend with HHS Secretary Robert F. Kennedy Jr.’s animosity like the traditional pharma industry, but his disinterest in distinguishing between the good and bad actors in the space could backfire.

Generic Drug Office’s Policy Staff Returning To US FDA

 

The group had been laid off as part of the 1 April reduction-in-force, which lead to missed guidance publication deadlines.

Pink Sheet Podcast: Prasad Staying Out Of Application Reviews, US FDA Proposed Budget Cuts

Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

More from Agency Leadership

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.

To Compete With China, US FDA Must Deregulate Early Gene Therapy Studies, CAR-T Inventor Says

 

FDA regulation was painted as an obstacle to US dominance in the cell and gene therapy space even as panelists at an agency event praised the Office of Therapeutic Products' track record under Nicole Verdun.

Delese Mimi Darko Appointed To Lead African Medicines Agency

 

Darko has become the first director-general of the AMA, an organization set up to transform access to quality-assured medicines across Africa and foster a more predictable, efficient regulatory environment for innovation.