WhenTakeda Pharmaceutical Co. Ltd. executives called into a mid-cycle communication teleconference with the FDA to discuss the status of the Entyvio (vedolizumab) BLA for ulcerative colitis and Crohn’s disease, they found quite an audience on the other end of the line: no fewer than 24 representatives from FDA, including three high-ranking agency officials.
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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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