Processes and Practices Applicable to Bioresearch Monitoring Inspections: Guidance for Industry

FDA 官方历史目录记录；Final guidance；发布日期：2025-12-19。官方主题：Clinical Trials, Compliance, Postmarket, Premarket, Investigation & Enforcement, Inspection, International, Administrative / Procedural, Bioequivalence, Biopharmaceutics, Biosimilars, Investigational New Drug Application (INDA), Food & Color Additives, Generic Drugs, HUD/HDE, Investigational Device Exemption (IDE), Premarket Approval (PMA), IVDs (In Vitro Diagnostic Devices), Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), Vaccines。请通过官方原文与附件查阅文件。