蒋千琴
FDA外审顾问
| 等级 | 已入驻 | 排行 | 文章数 | 热度 |
|---|---|---|---|---|
| 54 | 1 年 | 1 | 541 | 0 |
以下是作者 蒋千琴 的最新文章
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FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Draft
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Draft[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/28/2021 点赞 0 浏览 424 评论 0 -
FDA Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices [附网盘链接]是Food&Drug Administration于不久前发布的FDA标准，适用于U.S。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/28/2021 点赞 0 浏览 321 评论 0 -
FDA Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices
Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices[附网盘链接]是FDA于不久之前发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/27/2021 点赞 0 浏览 204 评论 0 -
FDA Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products
Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/27/2021 点赞 0 浏览 312 评论 0 -
FDA Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry
Consumer Antiseptic Wash Final Rule Questions and Answers Guidance for Industry[附网盘链接]是FDA于不久前发布的FDA标准，适用于US。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/26/2021 点赞 0 浏览 222 评论 0 -
FDA Contact Dermatitis From Topical Drug Products for Cutaneous Application Human Safety Assessment
Contact Dermatitis From Topical Drug Products for Cutaneous Application Human Safety Assessment[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/26/2021 点赞 0 浏览 200 评论 0 -
FDA Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry
Consumer Antiseptic Rub Final Rule Questions and Answers Guidance for Industry[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/25/2021 点赞 0 浏览 319 评论 0 -
FDA Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology
Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/25/2021 点赞 0 浏览 191 评论 0 -
FDA Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification
Considerations for Use of Histopathology and Its Associated Methodologies to Support Biomarker Qualification[附网盘链接]是FDA于当前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/24/2021 点赞 0 浏览 284 评论 0 -
FDA Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry
Considerations in Demonstrating Interchangeability With a Reference Product Guidance for Industry[附网盘链接]是Food And Drug Administration于当前发布的FDA标准，适用于United States。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/24/2021 点赞 0 浏览 358 评论 0 -
FDA Considerations for the Development of Dried Plasma Products Intended for Transfusion
Considerations for the Development of Dried Plasma Products Intended for Transfusion [附网盘链接]是FDA于过去发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/23/2021 点赞 0 浏览 321 评论 0 -
FDA Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于US。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/23/2021 点赞 0 浏览 195 评论 0 -
FDA Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency[附网盘链接]是FDA于之前发布的FDA标准，适用于U.S。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/22/2021 点赞 0 浏览 207 评论 0 -
FDA Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products
Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products[附网盘链接]是FDA于不久之前发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/22/2021 点赞 0 浏览 227 评论 0 -
FDA Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities
Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于美国。本次分享的标准文档为高清PDF（文字版），标准文档内可搜索，可复制，可粘贴。本文结尾附网盘链接。
12/21/2021 点赞 0 浏览 175 评论 0