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Recalls guidance

This article was originally published in The Gray Sheet

Executive Summary

Manufacturer recalls of FDA-regulated products that pose a "significant health hazard" should be announced via a press release through the Associated Press "to assure the broadest coverage," the agency suggests in a new 1industry guidance on product recalls, including removals and corrections. "For those recalls where FDA believes a press release is warranted, the agency will issue a press release if the firm has failed to do so, or if the firm-initiated press release is not adequate," the Oct. 30 guidance notes...
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