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Latest From Aventis SA
Consistency, Not Fireworks: US FDA’s Novel Approvals Times Stick Close To PDUFA Schedule
CDER holds steady with a median time to approval of 11 months, while CBER posts 10.5 month median review time for its largest novel approvals class.
End Of US FDA’s Very Fast Reviews? 2022 Novel Approvals Stayed Close To PDUFA Timeframes
Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year.
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