FDA Guidance Documents·· 原文未提供具体时分
Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff
Quality Management System Information for Certain Premarket Submission Reviews: Draft Guidance for Industry and Food and Drug Administration Staff
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FDA 官方历史目录记录；Draft guidance；发布日期：2025-10-27。官方主题：Current Good Manufacturing Practice (CGMP), HUD/HDE, Premarket Approval (PMA)。请通过官方原文与附件查阅文件。
来源：FDA Guidance Documents · fda.gov