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Inadequate Remediation Scope: The firm proposed to perform audit trail reviews for "active ingredient assays." The FDA deemed this inadequate because it excluded "other electronic laboratory data associated with component and finished-product testing".8 The requirement for data integrity applies to all CGMP data, including excipient testing, in-process checks, and stability data

Dapagliflozin improves cardiac autonomic function measures in type 2 diabetic patients with cardiac autonomic neuropathy

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This makes nutritional intake critical, necessitating frequent healthcare check-ins

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