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 Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry
Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities 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。
12/21/2021 点赞 0 浏览 227 评论 0 -
FDA Complicated Urinary Tract Infections Developing Drugs for Treatment
Complicated Urinary Tract Infections Developing Drugs for Treatment[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。
12/20/2021 点赞 0 浏览 204 评论 0 -
FDA Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act[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。
12/20/2021 点赞 0 浏览 177 评论 0 -
FDA Complicated Intra-Abdominal Infections Developing Drugs for Treatment
Complicated Intra-Abdominal Infections Developing Drugs for Treatment[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。
12/19/2021 点赞 0 浏览 206 评论 0 -
FDA Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations
Compliance with and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations[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。
12/19/2021 点赞 0 浏览 306 评论 0 -
FDA Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food
Compliance Policy Guide Sec. 555.400 Aflatoxins in Human Food[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。
12/18/2021 点赞 0 浏览 343 评论 0 -
FDA Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)
Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c)[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。
12/18/2021 点赞 0 浏览 524 评论 0 -
FDA Compliance Policy for Combination Product Postmarketing Safety Reporting Immediately in Effect
Compliance Policy for Combination Product Postmarketing Safety Reporting Immediately in Effect[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。
12/17/2021 点赞 0 浏览 263 评论 0 -
FDA Compliance Policy for Required Warning Statements on Small-Packaged Cigars Guidance for Industry
Compliance Policy for Required Warning Statements on Small-Packaged Cigars Guidance for Industry[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。
12/17/2021 点赞 0 浏览 408 评论 0 -
FDA Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco
Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco[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。
12/16/2021 点赞 0 浏览 306 评论 0 -
FDA Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect
Compliance Policy for Certain Compounding of Oral Oxitriptan (5-HTP) Drug Products for Patients With Tetrahydrobiopterin (BH4) Deficiency Immediately in Effect[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。
12/16/2021 点赞 0 浏览 337 评论 0 -
FDA Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry
Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry[附网盘链接]是FDA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。
12/15/2021 点赞 0 浏览 224 评论 0 -
FDA Competitive Generic Therapies
Competitive Generic Therapies[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。
12/15/2021 点赞 0 浏览 180 评论 0 -
FDA Comparability Protocols for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information
Comparability Protocols for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information[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。
12/14/2021 点赞 0 浏览 289 评论 0 -
FDA Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA Draft
Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA Draft[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。
12/14/2021 点赞 0 浏览 201 评论 0