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 Expansion Cohorts Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
Expansion Cohorts Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics[附网盘链接]是Food&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。
4/12/2022 点赞 0 浏览 285 评论 0 -
FDA Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers[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。
4/12/2022 点赞 0 浏览 472 评论 0 -
FDA Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency
Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency[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。
4/11/2022 点赞 0 浏览 386 评论 0 -
FDA Exculpatory Language in Informed Consent
Exculpatory Language in Informed Consent[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。
4/11/2022 点赞 0 浏览 515 评论 0 -
FDA Evaluation of Internal Standard Responses During Chromatographic Bioanalysis Questions and Answers
Evaluation of Internal Standard Responses During Chromatographic Bioanalysis Questions and Answers[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。
4/10/2022 点赞 0 浏览 284 评论 0 -
FDA Evaluation of Sex-Specific Data in Medical Device Clinical Studies -
Evaluation of Sex-Specific Data in Medical Device Clinical Studies -[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。
4/10/2022 点赞 0 浏览 272 评论 0 -
FDA Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents Study Design, Data Analysis, and Clinical Implications
Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents Study Design, Data Analysis, and Clinical Implications[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。
4/9/2022 点赞 0 浏览 258 评论 0 -
FDA Evaluation of Devices Used with Regenerative Medicine Advanced Therapies Guidance for Industry
Evaluation of Devices Used with Regenerative Medicine Advanced Therapies Guidance for Industry[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。
4/9/2022 点赞 0 浏览 197 评论 0 -
FDA Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies[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。
4/8/2022 点赞 0 浏览 247 评论 0 -
FDA Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern[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。
4/8/2022 点赞 0 浏览 262 评论 0 -
FDA Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Guidance for Industry
Evaluating Cancer Drugs in Patients with Central Nervous System Metastases Guidance for Industry[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。
4/7/2022 点赞 0 浏览 222 评论 0 -
FDA Evaluating Drug Effects on the Ability to Operate a Motor Vehicle
Evaluating Drug Effects on the Ability to Operate a Motor Vehicle[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。
4/7/2022 点赞 0 浏览 212 评论 0 -
FDA Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders[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。
4/6/2022 点赞 0 浏览 261 评论 0 -
FDA Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi[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。
4/6/2022 点赞 0 浏览 248 评论 0 -
FDA Establishing and FDA Establishing and Maintaining a List of U.S. Dairy Product ManufacturersProcessors with Interest in Exporting to Chile
Establishing and FDA Establishing and Maintaining a List of U.S. Dairy Product ManufacturersProcessors with Interest in Exporting to Chile[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。
4/5/2022 点赞 0 浏览 247 评论 0