FDA announced steps to strengthen the process for issuing warnings and notification of recalls, including a new draft guidance. According to the announcement, for FY 2018, there were a total of 7,420 recalls across FDA-regulated products, with 831 that were classified as the highest risk – representing a five-year low. The guideline’s purpose is to “assist and provide recommendations to industry and FDA staff regarding the use, content, and circumstances for issuance of public warnings and public notifications for firm-initiated or FDA-requested recalls.”
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