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Ground Hog Day For Merck: FDA Again Cancels Sugammadex Advisory Committee Review

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA is conducting additional inspections of the site of a hypersensitivity study the agency requested in 2008; concerns about the study derailed a committee review in 2013.

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Sugammadex Clinical Trial Issues Still Causing Trouble For Merck

After FDA abruptly cancelled an advisory committee meeting on the anesthesia injection product in July to review trial site inspection results for a hypersensitivity study, it issues a “complete response” letter indicating site “operational” concerns.

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