Back To White Oak: US FDA Adcomms Go Fully In-Person, Starting With Antimicrobials Panel

The 9 September meeting on Iterum Therapeutics' oral sulopenem product for uncomplicated urinary tract infections marks the first fully in-person advisory committee drug review since the COVID-19 pandemic hit in early 2020.

School bus
Like children returning to school, advisory committee members and public speakers will be returning to the FDA's White Oak headquarters in September. • Source: Shutterstock

The month of September will herald the first fully in-person US Food and Drug Administration advisory committee meeting on a new drug application since the start of the COVID-19 pandemic in 2020.

The Antimicrobial Drugs Advisory Committee is scheduled to meet on 9 September on discuss Iterum Therapeutics plc’s NDA for...

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

More from US FDA Performance Tracker

More from Regulatory Trackers