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 Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations
Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations[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。
2/11/2022 点赞 0 浏览 247 评论 0 -
FDA Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy
Determining Donor Eligibility for Autologous Donors of Blood and Blood Components Intended Solely for Autologous Use - Compliance Policy[附网盘链接]是FDA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。
2/11/2022 点赞 0 浏览 272 评论 0 -
FDA Design Considerations for Pivotal Clinical Investigations for Medical Devices Industry, Clinical Investigators, Institutional Review Boards and FDA Staff
Design Considerations for Pivotal Clinical Investigations for Medical Devices Industry, Clinical Investigators, Institutional Review Boards and FDA Staff[附网盘链接]是FDA于之前发布的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。
2/10/2022 点赞 0 浏览 291 评论 0 -
FDA Design Considerations for Devices Intended for Home Use
Design Considerations for Devices Intended for Home Use[附网盘链接]是Food&Drug Administration于不久之前发布的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。
2/10/2022 点赞 0 浏览 319 评论 0 -
FDA Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products
Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products[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。
2/9/2022 点赞 0 浏览 242 评论 0 -
FDA Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices
Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices[附网盘链接]是Food&Drug Administration于之前发布的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。
2/9/2022 点赞 0 浏览 289 评论 0 -
FDA Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway Draft
Denture Base Resins – Performance Criteria for Safety and Performance Based Pathway 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。
2/8/2022 点赞 0 浏览 222 评论 0 -
FDA Demonstrating the Substantial Equivalence of a New Tobacco Product Responses to Frequently Asked Questions
Demonstrating the Substantial Equivalence of a New Tobacco Product Responses to Frequently Asked Questions[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。
2/8/2022 点赞 0 浏览 237 评论 0 -
FDA Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products Draft[附网盘链接]是FDA于过去发布的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。
2/7/2022 点赞 0 浏览 179 评论 0 -
FDA Delayed Graft Function in Kidney Transplantation Developing Drugs for Prevention
Delayed Graft Function in Kidney Transplantation Developing Drugs for Prevention[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。
2/7/2022 点赞 0 浏览 198 评论 0 -
FDA Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act
Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act[附网盘链接]是FDA于过去发布的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。
2/6/2022 点赞 0 浏览 198 评论 0 -
FDA Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products
Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products[附网盘链接]是Food&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。
2/6/2022 点赞 0 浏览 232 评论 0 -
FDA Deciding When to Submit a 510(k) for a Change to an Existing Device
Deciding When to Submit a 510(k) for a Change to an Existing Device[附网盘链接]是Food&Drug Administration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。
2/5/2022 点赞 0 浏览 193 评论 0 -
FDA Deciding When to Submit a 510(k) for a Software Change to an Existing Device
Deciding When to Submit a 510(k) for a Software Change to an Existing Device[附网盘链接]是Food And Drug Administration于不久之前发布的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。
2/5/2022 点赞 0 浏览 247 评论 0 -
FDA Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry
Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry[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。
2/4/2022 点赞 0 浏览 231 评论 0