特定上市前提交审查的质量管理体系信息-2025草案_中英文版
ContainsNonbindingRecommendationsDraft–NotforImplementationQualityManagementSystemInformationforCertainPremarketSubmissionReviewsDraftGuidanceforIndustryandFoodandDrugAdministrationStaffDRAFTGUIDANCEThisdraftguidancedocumentisbeingdistributedforcommentpurposesonly.October2025Youshouldsubmitcommentsa...
2025-11-03
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