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 Chronic Hepatitis B Virus Infection Developing Drugs for Treatment
Chronic Hepatitis B Virus Infection Developing Drugs for Treatment[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。
11/28/2021 点赞 0 浏览 124 评论 0 -
FDA Chronic Fatigue SyndromeMyalgic Encephalomyelitis Developing Drug Products for Treatment
Chronic Fatigue SyndromeMyalgic Encephalomyelitis Developing Drug Products for Treatment[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。
11/28/2021 点赞 0 浏览 132 评论 0 -
FDA Chemotherapy-Induced Nausea and Vomiting Developing Drugs for Prevention Guidance for Industry Draft
Chemotherapy-Induced Nausea and Vomiting Developing Drugs for Prevention Guidance for Industry Draft[附网盘链接]是FDA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。
11/27/2021 点赞 0 浏览 152 评论 0 -
FDA Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry
Child-Resistant Packaging Statements in Drug Product Labeling Guidance for Industry[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。
11/27/2021 点赞 0 浏览 196 评论 0 -
FDA Chemistry, Manufacturing, and Controls Changes to an Approved Application Certain Biological Products
Chemistry, Manufacturing, and Controls Changes to an Approved Application Certain Biological Products[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。
11/26/2021 点赞 0 浏览 275 评论 0 -
FDA Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)[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。
11/26/2021 点赞 0 浏览 180 评论 0 -
FDA Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices
Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic 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。
11/25/2021 点赞 0 浏览 174 评论 0 -
FDA Charging for Investigational Drugs Under an IND - Questions and Answers Guidance for Industry
Charging for Investigational Drugs Under an IND - Questions and Answers Guidance for Industry[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。
11/25/2021 点赞 0 浏览 326 评论 0 -
FDA Changes to an Approved NDA or ANDA Guidance for Industry
Changes to an Approved NDA or ANDA Guidance for Industry[附网盘链接]是Food And 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。
11/24/2021 点赞 0 浏览 400 评论 0 -
FDA Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act
Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act[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。
11/24/2021 点赞 0 浏览 244 评论 0 -
FDA Changes to an Approved Application Biological Products Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Final Guidance
Changes to an Approved Application Biological Products Human Blood and Blood Components Intended for Transfusion or for Further Manufacture Final Guidance[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。
11/23/2021 点赞 0 浏览 228 评论 0 -
FDA CGO Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli
CGO Sec 540.275 (Draft) Crabmeat - Fresh and Frozen - Adulteration with Filth, Involving the Presence of Escherichia coli[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。
11/23/2021 点赞 0 浏览 189 评论 0 -
FDA Certificates of Confidentiality Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff
Certificates of Confidentiality Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff[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。
11/22/2021 点赞 0 浏览 278 评论 0 -
FDA Certification Process of Designated Medical Gases
Certification Process of Designated Medical Gases[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。
11/22/2021 点赞 0 浏览 222 评论 0 -
FDA Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus Draft
Certain Medical Devices Intended to Therapeutically Improve Glycemic Control in Patients with Type 2 Diabetes Mellitus Draft[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。
11/21/2021 点赞 0 浏览 305 评论 0