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

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