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

 
• By Sue Sutter

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 oral sulopenem etzadroxil/probenecid tablets

Key Takeaways

  • The public may attend the 9 September Antimicrobial Drugs Advisory Committee meeting to discuss Iterum Therapeutics’ oral sulopenem product in person or virtually.

  • The meeting is the first fully in-person adcomm on a drug application scheduled since the start of the COVID-19 pandemic

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