The median review times for US Food and Drug Administration-approved novel agents in 2024 held very close to Prescription Drug User Fee Act goals, highlighting the fundamental predictability of the review process even as missed user fee goal dates and complete response letters have increased.
US FDA’s Median Review Time Remains Less Than One Year Despite Swell Of Missed Goal Dates
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.
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