Hurricane Sandy Rains On User Fee Dates, Advisory Committees
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.
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FDA missed its deadline to post the advisory committee briefing materials then postponed the meeting as a winter storm headed towards Washington.
If approved, Zohydro will be the first extended-release version of hydrocodone and the first not to be combined with other painkillers.