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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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More from Pathways & Standards

US FDA User Fee Collection Safe In Preliminary Trump 2026 Budget Plan

 
• By Cathy Kelly

The preliminary White House 2026 budget plan cuts agency funding, but not so sharply that user fees are excluded from collection.

New EU Approvals

 
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Tivdak, Pfizer/Genmab’s treatment for previously treated recurrent or metastatic cervical cancer.

Industry Keen On ‘Stepwise’ PIPs, But Future Hinges On EU Pharma Legislation Reform

 
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