1. Pink Sheet
  2. >>Agency Leadership
  3. >>US FDA

Shutdown Threat Forced US FDA To Cancel Some Travel

 
• By Derrick Gingery

Several FDA staffers presented at the RAPS Convergence conference via Zoom and pre-recorded video instead, illustrating that just the threat of a shutdown can scramble FDA plans.

Janet Woodcock at RAPS Convergence 2023
Janet Woodcock appeared at the RAPS Convergence conference in person, while other agency officials had to appear virtually. • Source: Derrick Gingery

Many US Food and Drug Administration officials apologized at the beginning of their talks during the Regulatory Affairs Professionals Society Convergence conference. Not for a controversial new guidance or proposed rule, but because they were not there in person.

As Congress barreled toward a government shutdown during the final days of September, the FDA canceled scheduled trips to Montréal,...

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

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision

 
• By Sarah Karlin-Smith

The FDA law establishing REMS authority does not preempt a West Virginia law that would restrict mifepristone use in the state, an appeals court said, a decision that could have broader ramifications for the agency’s authority to ensure drug access.

US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming

 
• By Derrick Gingery, Sue Sutter, and Sarah Karlin-Smith

The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.

Consumer Groups Have A ‘Radical Transparency’ List For US FDA’s PDUFA VIII

 
• By Sarah Karlin-Smith

Development of the user fee commitment letter largely takes place behind closed doors between industry and FDA. Outside groups see the upcoming negotiation cycle as a chance to change this and other agency information blocks by reminding Commissioner Makary of his commitment to transparency.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.

More from Conferences

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 
• By Sarah Karlin-Smith

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.

US FDA’s Elsa AI Platform Is Not Guiding Regulatory Decisions, Official Says

 
• By Cathy Kelly

Tala Fakhouri said the agency’s use of the AI tool in the review process has generated lots of questions.