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US FDA’s Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates

 
• By Bridget Silverman

Novel agents from the biologics center had a median review time of 10.6 months, beating the drugs center's median of 11.8 months thanks to fewer multicycle and more priority reviews.

Pink Sheet Perspectives
The US FDA stayed on top of review times for novel agents in 2024, keeping close to PDUFA timetables. (Shutterstock)
Key Takeaways
  • The time between submission and approval continued to creep upward in 2024, with a median of 11.7 months for the US FDA’s novel approvals.

The median review times for US Food and Drug Administration-approved novel agents in 2024 held very close to Prescription Drug...

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