2.4 INFORMATION FOR右侧下方INFORMATION FOR一栏针对不同的对象分别提供了相应的资源,体现了有的放矢的服务,例如针对Consumers(消费者),提供了各种产品健康和安全信息,以便让广大消费者放心;针对Patients(病人),提供了多种治疗方案、批准上市的药物和医疗器械等,为病人康复指引了方向;针对Industry(工业界人士),提供了指南...
具体步骤可见http://www.fda.gov/downloads/ForIndustry/DataStandards/StructuredProductLabeling/UCM162027.pdf <工厂注册和产品登记的SPL文件编写的分步教程> C.必须提交的文件的准备 说明: ①用GUIDGen.exe或在线生成’id root’或’Set ID root’,这两个都是GUID(Globally Unique Identifier),前者表示一个SPL文...
UNII(Unique ingredient identifier-必填项,可以去http://www./ForIndustry/DataStandards/StructuredProductLabeling/ucm162523.htm 点击下载连接下载所有产品的UNII,也可以去http://fdasis.nlm./srs/srs.jsp 搜索要登记的产品)还有strength(一般是比例的形式,每g或每kg含多少活性成分) ...
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/medical-device-classification-product-codes-guidance-industry-and-food-and-drug-administration-staff 其中所提及的 pre-amendments device定义如下: The term "preamendments device" refers to devices legally marketed in the U.S. by ...
PRODUCTCODESPRODUCT/ASSIGNMENTCODE(PAC) 产品代码产品/任务代码(PAC) HumanDrugsIndustryCodes:PACSubject 人类药品行业PACSubject公司 代码:56843Post-approvalInspections 50,54–56,59,60–66.56843批准后检查 50、54-56、59、60-66。56R927RemoteInteractiveEvaluation(RIE)Activities— HumanDrugs 56R927远程交互评估(RI...
美国FDA指导原则 Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.docx,Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Qua
▲Guidance for Industry Forms for Registration of Producers of Drugsand Listing of Drugs in Commercial Distribution 200104 工业指南 药品生产者注册和商业流通领域的药品清单200104 ▲Registration of Drug Establishment Labeler Code Assignment 药厂注册的标签编号方法 ...
参考资料GuidanceforIndustryBACPACI:IntermediatesinDrugSubstanceSynthesisGuidanceforIndustry:ChangestoanApprovedNDAorANDADrugMasterFiles:://fda.gov/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/DrugMasterFilesDMFs/default.htmGuidanceforIndustry:ProvidingRegulatorySubmissionsinElectronicFormat–DrugEstablishment...
Orange Book Questions and Answers Guidance for Industry 行业指南草案:橙皮书问答 This draft guidance, when finalized, will represent the current thinking of the Foodand Drug Administration (FDA or Agency) on this topic. It does not establish any rights for an...
号。参考资料参考资料vGuidance for Industry BACPAC I: Intermediates in Drug Substance Synthesis vGuidance for Industry:Changes to an Approved NDA or ANDAvDrug Master Files: vGuidance for Industry : Providing Regulatory Submissions in Electronic Format Drug Establishment Registration and Drug Listing...