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 Bioanalytical Method Validation Guidance for Industry
Bioanalytical Method Validation Guidance for Industry[附网盘链接]是Food&Drug Administration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。
11/6/2021 点赞 0 浏览 141 评论 0 -
FDA Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics and Food and Drug Ad
Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics and Food and Drug Ad[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。
11/5/2021 点赞 0 浏览 145 评论 0 -
FDA Best Practices for Communication Between IND Sponsors and FDA During Drug Development
Best Practices for Communication Between IND Sponsors and FDA During Drug Development[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。
11/5/2021 点赞 0 浏览 186 评论 0 -
FDA Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval
Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval[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。
11/4/2021 点赞 0 浏览 181 评论 0 -
FDA Bacterial Vaginosis Developing Drugs for Treatment Guidance for Industry
Bacterial Vaginosis Developing Drugs for Treatment Guidance for Industry[附网盘链接]是Food&Drug Administration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。
11/4/2021 点赞 0 浏览 285 评论 0 -
FDA Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion[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。
11/3/2021 点赞 0 浏览 285 评论 0 -
FDA Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer Developing Drugs and Biologics for Treatment
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer Developing Drugs and Biologics for Treatment[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。
11/3/2021 点赞 0 浏览 240 评论 0 -
FDA Atopic Dermatitis Timing of Pediatric Studies During Development of Systemic Drugs
Atopic Dermatitis Timing of Pediatric Studies During Development of Systemic Drugs[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。
11/2/2021 点赞 0 浏览 265 评论 0 -
FDA Attention Deficit Hyperactivity Disorder Developing Stimulant Drugs for Treatment
Attention Deficit Hyperactivity Disorder Developing Stimulant Drugs for Treatment[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。
11/2/2021 点赞 0 浏览 153 评论 0 -
FDA Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices
Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices[附网盘链接]是Food And Drug Administration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。
11/1/2021 点赞 0 浏览 185 评论 0 -
FDA Assessment of Pressor Effects of Drugs Guidance for Industry
Assessment of Pressor Effects of Drugs Guidance for Industry[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。
11/1/2021 点赞 0 浏览 242 评论 0 -
FDA Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications Draft
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications Draft[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。
10/31/2021 点赞 0 浏览 166 评论 0 -
FDA Assessment of Abuse Potential of Drugs
Assessment of Abuse Potential of Drugs[附网盘链接]是FDA于不久前发布的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。
10/30/2021 点赞 0 浏览 142 评论 0 -
FDA Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017
Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017[附网盘链接]是Food And Drug Administration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。
10/29/2021 点赞 0 浏览 200 评论 0 -
FDA Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry
Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 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。
10/28/2021 点赞 0 浏览 276 评论 0