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For CDMOs, contract testing laboratories and other outsourced manufacturers, the implications are particularly significant the FDA considers contractors extensions of the manufacturer, meaning AI governance gaps at a contract facility can directly translate into compliance risk for the sponsor

Received 2024-3-26

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They verify the peptide sequence by HPLC and mass spectrometry, certify the tripeptide purity, and ship the product without ever confirming whether the copper is actually bound

Some insurers require an MDs name on prior authorizations for GLP-1s, even if the NP legally could prescribe alone