1. Pink Sheet

House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval

 
• By Derrick Gingery

Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.

Anna Eshoo speaks during Energy and Commerce Committee mark-up
Rep. Anna Eshoo discussed the FDA user fee reauthorization and other bills during a House Energy and Commerce Committee mark-up. • Source: Screenshot

Despite concerns from the brand industry, no major changes were made to provisions in the US Food and Drug Administration’s user fee reauthorization bill allowing generic drug sponsors more inactive ingredient information as it breezed to the House floor.

The bill would require the FDA to tell generic drug sponsors whether their products are qualitatively and quantitatively the same as the reference product, and if not, give the exact...

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