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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.

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