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 – 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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Next iteration of PDUFA will feature new communication plans that allow FDA and sponsors to drop mid-review meetings if desired.
Early feedback on FDA’s review “Program” for new drugs and biologics is cautiously optimistic. FDA is meeting user fee goals. Communication between reviewers and drug sponsors has dramatically improved. And even trickier applications have done unusually well at advisory committee meetings. But FDA’s John Jenkins acknowledges that a lack of resources is straining the system – and forcing the agency to adapt.
Industry came to the PDUFA V negotiating table with one big agenda item: improved communication with FDA officials about a product under review. They succeeded, but it came with a price: an extra two months for FDA to review an application. While it may seem like things just went back to 2002, both industry and the agency say it could actually lead to faster approvals.