Merck Went Own Way On Bezlotoxumab Endpoint And FDA May Not Follow
This article was originally published in The Pink Sheet Daily
Merck rejected FDA's recommended endpoint to show efficacy in preventing C. difficile recurrence, which could make it difficult to gain approval for the product, headed to June 9 advisory panel review.
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Our infographic illustrates the recommendations in FDA’s COVID-19 pandemic recovery and preparedness plan, ranging from strengthening the EUA process to managing the backlog of pending inspections.