Gottlieb Tweets FDA Shutdown Details, Says Guidance Coming Soon

Over the holidays and the first days of January, FDA Commissioner Scott Gottlieb issued a steady stream of tweets in a bid to answer stakeholders’ questions about which agency activities are on hold during the partial government shutdown, including user fee-related application reviews, certain medical and over-the-counter product reviews, and non-emergency work on certain biologic products. He also highlighted activities that remain operational, including review of submissions that do not require user fees and actions related to tobacco oversight and...