1. Pink Sheet
  2. >>Pathways & Standards

FDA Reforms Missed By FDORA Could Find Vehicle In Animal Drug User Fee, Pandemic Bills

 
• By Derrick Gingery

The usually lower-profile user fee reauthorizations could gain more attention for broader US FDA issues, said Andi Lipstein Fristedt, FDA deputy commissioner for policy, legislation and international affairs.

US flags perspectives
The FDA also wants the must-pass ADUFA and AGDUFA bills to pass well before the programs' expiration date. • Source: Shutterstock

A lesser known must-pass bill coming up this year could be one of the potential vehicles for US Food and Drug Administration reforms that were left out of the 2022 human drug, biosimilar and device user fee reauthorization package.

With the House of Representatives and Senate controlled by different parties that have divergent priorities, additions that could be included...

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

US FDA’s CoGenT Pilot At Risk? Project Orbis Success May Not Save Cell/Gene Therapy Initiative

 
• By Bridget Silverman

Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.

Kisunla Back In The Spotlight As EMA Reconsiders Alzheimer’s Drug Rejection

 
• By Eliza Slawther

It appears that the European Medicines Agency is making progress on its re-examination of Eli Lilly’s Alzheimer’s disease drug Kisunla, following an initial rejection in March based on safety concerns.

Alzheimer’s Drug Leqembi May Be On Course To India, Kisunla In The Wings

 
• By Anju Ghangurde

Key expert panel go-ahead with a trial waiver put’s Eisai's Alzheimer's therapy on track for a debut in India where tailored pricing will be pivotal. Lilly’s Kisunla is also under regulatory review.