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FDA Final Guidance: Public Warning and Notification of Recalls

February 13, 2019

Last week, FDA Commissioner Gottlieb issued a press statement indicating FDA has finalized guidance for industry and FDA staff entitled “Public Warning and Notification of Recalls.”  Although FDA recognized that industry is generally effective in rapidly initiating voluntary recalls and removing products from shelves as necessary, the Agency indicated that in certain scenarios the Agency may need to provide additional information.  FDA indicates that the guidance will help address these scenarios by outlining circumstances when a company should issue a public warning about a voluntary recall, the time frame for companies to issue such a warning, and information to be included.

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