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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.

The FDA's review operations stayed on track despite the challenging environment in Q1 2025. (Shutterstock)
Key Takeaways
  • The US FDA acted on 15 novel agents in Q1 2025, producing 10 approvals and five complete response letters.
  • The first three months of 2025 included the fewest novel approvals since 2019, but the Q1 share of full-year approvals is variable, ranging between 13% and 27%
  • The second quarter opened with one complete response letter and no action from the FDA on the 1 April goal date for Novavax's COVID-19 vaccine.

Despite the ongoing upheaval across the agency, the US Food and Drug Administration maintained its typical reliability when it came to meeting user fee goal dates in the first quarter...

The full impact of cuts to FDA staff, from senior...

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