GSK’s Breo Ellipta Gets “Snowquestered” As FDA Delays Advisory Cmte
This article was originally published in The Pink Sheet Daily
FDA missed its deadline to post the advisory committee briefing materials then postponed the meeting as a winter storm headed towards Washington.
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FDA is facing several novel candidates for chronic obstructive pulmonary disease in 2013; those products should expect close scrutiny due to past issues with class safety and new signals in clinical trials.
FDA will extend user fee goal dates as needed to account for the loss of two days in review cycles resulting from the government office shutdown. The extreme weather conditions led to cancellation of three advisory committees during the week of Oct. 29.