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FDA Review “Program” Tweaks May Include Smaller Mid-Cycle Meetings

Executive Summary

Mid-cycle meetings under FDA’s review “Program” have ballooned into 30- to 40-person affairs – far larger than originally envisioned under PDUFA V – making mid-cycle calls difficult to schedule, especially for expedited products with tight review timeframes. It is one lesson learned from the Program’s first 18 months.


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