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 Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions
Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions[附网盘链接]是FDA于不久前发布的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。
10/3/2021 点赞 0 浏览 190 评论 0 -
FDA Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval;
Acceptability of Draft Labeling to Support Abbreviated New Drug Application Approval;[附网盘链接]是FDA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。
10/2/2021 点赞 0 浏览 208 评论 0 -
FDA Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)
Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)[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。
10/2/2021 点赞 0 浏览 249 评论 0 -
FDA Abuse-Deterrent Opioids-Evaluation and Labeling
Abuse-Deterrent Opioids-Evaluation and Labeling[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。
10/1/2021 点赞 0 浏览 325 评论 0 -
FDA A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Draft
A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Draft[附网盘链接]是Food And 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。
10/1/2021 点赞 0 浏览 279 评论 0 -
FDA 510(k) Third Party Review Program Industry, Food and Drug Administration Staff, and Third Party Review Organizations
510(k) Third Party Review Program Industry, Food and Drug Administration Staff, and Third Party Review Organizations[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。
9/30/2021 点赞 0 浏览 176 评论 0 -
FDA A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part II
A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part II[附网盘链接]是FDA于过去发布的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。
9/30/2021 点赞 0 浏览 213 评论 0 -
FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device ApplicationsSubmissions
3674 - Certifications To Accompany Drug, Biological Product, and Device ApplicationsSubmissions[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。
9/30/2021 点赞 0 浏览 176 评论 0 -
FDA 30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes
30-Day Notices, 135-Day Premarket Approval (PMA) Supplements and 75-Day Humanitarian Device Exemption (HDE) Supplements for Manufacturing Method or Process Changes[附网盘链接]是Food And Drug Administration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。
9/29/2021 点赞 0 浏览 360 评论 0 -
FDA 2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry
2016 Medical Gas Container-Closure Rule Questions and Answers Guidance for Industry[附网盘链接]是Food&Drug Administration于当前发布的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。
9/29/2021 点赞 0 浏览 191 评论 0 -
FDA #267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs
#267 Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs[附网盘链接]是Food And 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。
9/28/2021 点赞 0 浏览 324 评论 0 -
FDA (510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation
(510(k)) Submissions for Nucleic Acid-Based Human Leukocyte Antigen (HLA) Test Kits Used for Matching of Donors and Recipients in Transfusion and Transplantation[附网盘链接]是Food And 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。
9/28/2021 点赞 0 浏览 295 评论 0 -
FDA #178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims
#178 Recommended Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims[附网盘链接]是FDA于当前发布的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。
9/27/2021 点赞 0 浏览 253 评论 0 -
FDA #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs
#265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs[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。
9/27/2021 点赞 0 浏览 338 评论 0