1. Generics Bulletin
  2. >>Policy & Regulation

FDA Gives Congress Reprieve On Deadline For Passing User Fee Bill

 
• By Derrick Gingery

Commissioner Gottlieb says agency won't issue layoff notices 'unless and until Sept. 30 passes without reauthorization.'

FDA entrance sign 2016

In a memo sent to all employees July 24, Gottlieb said the agency has determined that it will not send reduction in force (RIF) notices on Aug. 1 to employees that could lose their jobs if the FDA Reauthorization Act (FDARA) is not enacted by Oct. 1. Legally, FDA must tell employees who are supported by user fee revenue at least 60 days in advance that they could be let go.

Gottlieb wrote that "because we can reasonably expect that there will be timely reauthorization of the user fee programs by...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin 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 Policy & Regulation

More from Generics Bulletin

Celltrion Reinforces Commitment To UK Biosimilars Market With New HQ

 
• By Dave Wallace

Celltrion has reinforced its commitment to the UK by opening a new central operations hub in Uxbridge, while acknowledging that “major questions over the attractiveness of the market” need to be addressed to encourage development and ensure a sustainable environment for UK biosimilars.

‘Prices Can Remain Contaminated Indefinitely’: Advanz Brushed Aside On UK Liothyronine Appeal

 
• By Dean Rudge

England’s Court of Appeal has upheld a Competition Appeal Tribunal’s 2023 finding that Advanz and its former owner Cinven abused their dominant position in the UK market for liothyronine tablets by charging prices that were many orders of magnitude higher than the benchmark for fair pricing.

Tevogen Will House Generics Unit In Much-Expanded New Headquarters

 
• By Dean Rudge

Tevogen is looking to accelerate its growth with a major expansion of its headquarters in Warren, New Jersey, more than doubling its footprint to centralize research and development, regulatory, and corporate functions. The new facility will support the company’s evolving initiatives.