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Just the facts maam

05/07/24 4:12 PM

#14880 RE: Easka #14879

Easka, it appears that the FDA appear to give more time before issuing a pre-notice which informs the company that they have 30 days to submit result or risk facing fines for non- compliance. Companies usually post results shortly after receiving the pre-notice. Technically, the are at risk of facing fines now, but it is unlikely as long as they submit the results upon receiving the pre-notice, or sooner. The FDA shoots for posting pre-notices that were issued every quarter.