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 Center for Devices and Radiological Health (CDRH) Appeals Processes
Center for Devices and Radiological Health (CDRH) Appeals Processes[附网盘链接]是Food And 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。
11/21/2021 点赞 0 浏览 285 评论 0 -
FDA Center for Devices and Radiological Health (CDRH) Appeals Processes Questions and Answers About 517A
Center for Devices and Radiological Health (CDRH) Appeals Processes Questions and Answers About 517A[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。
11/20/2021 点赞 0 浏览 247 评论 0 -
FDA CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality
CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality[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。
11/20/2021 点赞 0 浏览 263 评论 0 -
FDA Case Presentations During Investigational Device Exemption (IDE) Clinical Trials
Case Presentations During Investigational Device Exemption (IDE) Clinical Trials[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。
11/19/2021 点赞 0 浏览 207 评论 0 -
FDA Cannabis and Cannabis-Derived Compounds Quality Considerations for Clinical Research
Cannabis and Cannabis-Derived Compounds Quality Considerations for Clinical Research[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。
11/19/2021 点赞 0 浏览 120 评论 0 -
FDA Cancer Clinical Trial Eligibility Criteria Patients with Organ Dysfunction or Prior or Concurrent Malignancies
Cancer Clinical Trial Eligibility Criteria Patients with Organ Dysfunction or Prior or Concurrent Malignancies[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。
11/18/2021 点赞 0 浏览 122 评论 0 -
FDA Cancer Clinical Trial Eligibility Criteria Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections
Cancer Clinical Trial Eligibility Criteria Patients with HIV, Hepatitis B Virus, or Hepatitis C Virus Infections[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。
11/18/2021 点赞 0 浏览 144 评论 0 -
FDA Cancer Clinical Trial Eligibility Criteria Minimum Age Considerations for Inclusion of Pediatric Patients
Cancer Clinical Trial Eligibility Criteria Minimum Age Considerations for Inclusion of Pediatric Patients[附网盘链接]是FDA于不久之前发布的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。
11/17/2021 点赞 0 浏览 177 评论 0 -
FDA Cancer Clinical Trial Eligibility Criteria Brain Metastases
Cancer Clinical Trial Eligibility Criteria Brain Metastases[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。
11/17/2021 点赞 0 浏览 160 评论 0 -
FDA Cancer Clinical Trial Eligibility Criteria Available Therapy in Non-Curative Settings Draft
Cancer Clinical Trial Eligibility Criteria Available Therapy in Non-Curative Settings Draft[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。
11/16/2021 点赞 0 浏览 146 评论 0 -
FDA c Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program
c Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program[附网盘链接]是FDA于不久之前发布的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。
11/16/2021 点赞 0 浏览 218 评论 0 -
FDA Bundling Multiple Devices or Multiple Indications in a Single Submission
Bundling Multiple Devices or Multiple Indications in a Single Submission[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。
11/15/2021 点赞 0 浏览 223 评论 0 -
FDA c Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program(1)
c Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program(1)[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。
11/15/2021 点赞 0 浏览 234 评论 0 -
FDA Bridging for Drug-Device and Biologic-Device Combination Products Draft Guidance for Industry
Bridging for Drug-Device and Biologic-Device Combination Products Draft Guidance for Industry[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。
11/14/2021 点赞 0 浏览 192 评论 0 -
FDA Brief Summary and Adequate Directions for Use Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs
Brief Summary and Adequate Directions for Use Disclosing Risk Information in Consumer-Directed Print Advertisements and Promotional Labeling for Prescription Drugs[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。
11/14/2021 点赞 0 浏览 116 评论 0