蒋千琴

蒋千琴

FDA外审顾问

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以下是作者 蒋千琴 的最新文章

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  • FDA De Novo Classification Process (Evaluation of Automatic Class III Designation)

    FDA De Novo Classification Process (Evaluation of Automatic Class III Designation)

    De Novo Classification Process (Evaluation of Automatic Class III Designation)[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。

    2/4/2022 点赞 0 浏览 196 评论 0
  • FDA CVM GFI #85 (VICH GL9) Good Clinical Practice

    FDA CVM GFI #85 (VICH GL9) Good Clinical Practice

    CVM GFI #85 (VICH GL9) Good Clinical Practice[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。

    2/3/2022 点赞 0 浏览 217 评论 0
  • FDA Cytomegalovirus in Transplantation Developing Drugs to Treat or Prevent Disease

    FDA Cytomegalovirus in Transplantation Developing Drugs to Treat or Prevent Disease

    Cytomegalovirus in Transplantation Developing Drugs to Treat or Prevent Disease[附网盘链接]是FDA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。

    2/3/2022 点赞 0 浏览 216 评论 0
  • FDA CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM

    FDA CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM

    CVM GFI #79 Dispute Resolution Procedures for Science-Based Decisions on Products Regulated by CVM[附网盘链接]是Food&Drug Administration于当前发布的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。

    2/2/2022 点赞 0 浏览 164 评论 0
  • FDA CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADAANADA

    FDA CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADAANADA

    CVM GFI #83 Chemistry, Manufacturing and Controls Changes to Approved NADAANADA[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。

    2/2/2022 点赞 0 浏览 346 评论 0
  • FDA CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs

    FDA CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs

    CVM GFI #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs[附网盘链接]是FDA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。

    2/1/2022 点赞 0 浏览 239 评论 0
  • FDA CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency

    FDA CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency

    CVM GFI #271 Reporting and Mitigating Animal Drug Shortages during the COVID-19 Public Health Emergency[附网盘链接]是Food And Drug Administration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。

    2/1/2022 点赞 0 浏览 208 评论 0
  • FDA CVM GFI #264 Standardized Medicated Feed Assay Limits

    FDA CVM GFI #264 Standardized Medicated Feed Assay Limits

    CVM GFI #264 Standardized Medicated Feed Assay Limits[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。

    1/31/2022 点赞 0 浏览 305 评论 0
  • FDA CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs

    FDA CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs

    CVM GFI #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs[附网盘链接]是Food&Drug Administration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。

    1/31/2022 点赞 0 浏览 278 评论 0
  • FDA CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances

    FDA CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances

    CVM GFI #256 - Compounding Animal Drugs from Bulk Drug Substances[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。

    1/30/2022 点赞 0 浏览 202 评论 0
  • FDA CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

    FDA CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

    CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal 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。

    1/30/2022 点赞 0 浏览 181 评论 0
  • FDA CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting

    FDA CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting

    CVM GFI #252 Small Entity Compliance Guide Antimicrobial Animal Drug Sales and Distribution Reporting[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。

    1/29/2022 点赞 0 浏览 224 评论 0
  • FDA CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers

    FDA CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers

    CVM GFI #255 Elemental Impurities in Animal Drug Products Questions and Answers[附网盘链接]是Food&Drug Administration于之前发布的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。

    1/29/2022 点赞 0 浏览 262 评论 0
  • FDA CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

    FDA CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals

    CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals[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。

    1/28/2022 点赞 0 浏览 214 评论 0
  • FDA CVM GFI #240 Proprietary Names for New Animal Drugs

    FDA CVM GFI #240 Proprietary Names for New Animal Drugs

    CVM GFI #240 Proprietary Names for New Animal Drugs[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。

    1/28/2022 点赞 0 浏览 217 评论 0