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US FDA's Delay In Acting On Moderna RSV Vaccine Adds To Growing List of User Fee Goal Misses

 
• By Bridget Silverman

Administrative constraints adds Moderna’s mRNA-1345 to the recently increasing number of US FDA user fee goal date misses.

delay
Missed user fee goal date are becoming more common place for novel products. • Source: Shutterstock

Moderna, Inc.’s respiratory syncytial virus vaccine will become the next application to miss its Prescription Drug User Fee Act goal date for a US Food and Drug Administration decision, suggesting that the agency may be growing more comfortable missing targets.

Key Takeaways:

  • The FDA expects to act on the Moderna RSV vaccine BLA by the end of May after missing its 12 May user fee...

“Administrative constraints” will prevent the FDA from meeting the 12 May 2024 user fee goal for Moderna’s mRNA-1345, the company announced 10 May.

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