1. Pink Sheet
  2. >>Pathways & Standards
  3. >>User Fees

US FDA's Biologics Center May Get Its Day In PDUFA VII

 
• By Derrick Gingery

Multiple stakeholders call for CBER to receive more prescription drug user fee funds amid growing cell and gene therapy popularity.

FDA entrance sign 2016
FDA and industry representatives are preparing for PDUFA reauthorization talks to begin this fall. • Source: File photo

The bright lights of the prescription drug user fee program may be ready to shift more toward the US Food and Drug Administration’s biologics center.

Multiple industry and stakeholder groups indicated that a tidal wave of work is bearing down on the Center for Biologics...

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 User Fees

More from Pathways & Standards

House Gives US FDA More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

Julian Beach, interim executive director of healthcare quality and access at the UK drug regulator, the MHRA, tells the Pink Sheet how the agency is responding to increased efforts to develop bacteriophage therapies.

LDT Final Act? US FDA Will Not Appeal District Court Decision Vacating Final Rule

 
• By Brian Bossetta

The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.