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 Development of Anti-Infective Drug Products for the Pediatric Population Draft
Development of Anti-Infective Drug Products for the Pediatric Population Draft[附网盘链接]是Food&Drug Administration于当前发布的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。
2/19/2022 点赞 0 浏览 223 评论 0 -
FDA Development and Use of Risk Minimization Action Plans Guidance for Industry
Development and Use of Risk Minimization Action Plans Guidance for Industry[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。
2/18/2022 点赞 0 浏览 243 评论 0 -
FDA Development of a Shared System REMS Guidance for Industry
Development of a Shared System REMS 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。
2/18/2022 点赞 0 浏览 210 评论 0 -
FDA Development and Submission of Near Infrared Analytical Procedures
Development and Submission of Near Infrared Analytical Procedures[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。
2/17/2022 点赞 0 浏览 167 评论 0 -
FDA Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry
Development and Licensure of Vaccines to Prevent COVID-19 Guidance for Industry[附网盘链接]是Food&Drug Administration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。
2/17/2022 点赞 0 浏览 256 评论 0 -
FDA Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease
Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease[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。
2/16/2022 点赞 0 浏览 254 评论 0 -
FDA Developing Medical Imaging Drug and Biological Products Part 3 Design, Analysis, and Interpretation of Clinical Studies
Developing Medical Imaging Drug and Biological Products Part 3 Design, Analysis, and Interpretation of Clinical Studies[附网盘链接]是Food And 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。
2/16/2022 点赞 0 浏览 305 评论 0 -
FDA Developing Medical Imaging Drug and Biological Products Part 1 Conducting Safety Assessments
Developing Medical Imaging Drug and Biological Products Part 1 Conducting Safety Assessments[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。
2/15/2022 点赞 0 浏览 308 评论 0 -
FDA Developing Medical Imaging Drug and Biological Products Part 2 Clinical Indications
Developing Medical Imaging Drug and Biological Products Part 2 Clinical Indications[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。
2/15/2022 点赞 0 浏览 229 评论 0 -
FDA Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data[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。
2/14/2022 点赞 0 浏览 250 评论 0 -
FDA Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions
Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions[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。
2/14/2022 点赞 0 浏览 242 评论 0 -
FDA Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products
Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products[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。
2/13/2022 点赞 0 浏览 370 评论 0 -
FDA Determining Whether to Submit an ANDA or a 505(b)(2) Application
Determining Whether to Submit an ANDA or a 505(b)(2) Application[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。
2/13/2022 点赞 0 浏览 213 评论 0 -
FDA Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507
Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507[附网盘链接]是Food&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。
2/12/2022 点赞 0 浏览 319 评论 0 -
FDA Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products[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。
2/12/2022 点赞 0 浏览 294 评论 0