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Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Agency IQ

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA 40
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Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA 40