FDA Electronic Submission of Lot Distribution Reports Guidance for Industry
标准简介
Electronic Submission of Lot Distribution Reports 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United States。标准截图
![Electronic Submission of Lot Distribution Reports Guidance for Industry[附网盘链接]](/img/20210914103737q3cu2.jpg)
标准文档说明
标准文档类型为Electronic Submission of Lot Distribution Reports Guidance for Industry[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Electronic Submission of Lot Distribution Reports Guidance for Industry This guidance represents the Food and Drug Administration’s (FDA’s or Agency’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance using the contact information on the title page of this guidance. I. INTRODUCTION This guidance provides you, licensed manufacturers of products distributed under an approved biologics license application (BLA) (henceforth referred to as applicants), with recommendations on how to submit lot distribution reports (LDRs) for biological products in an electronic format that FDA can process, review, and archive. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe FDA’s current thinking on a topic, and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required.
网盘链接
百度网盘：https://pan.baidu.com/s/1GChCsaBm0yFuuYRL4yNuCQ
提取码：7kf8
【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。
加载用时：47.3776 毫秒
相关评论
相关文章
-
FDA Electronic Submission of IND Safety Reports Technical Conformance Guide Guidance for Industry
Electronic Submission of IND Safety Reports Technical Conformance Guide Guidance for Industry[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。
-
IMDRF/RPS WG/N32 FINAL: 2015 Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)
Strategic Assessment of Electronic Submission Messaging Formats - PDF (242Kb)[附网盘链接]是IMDRF RPS WG于2 October 2015发布的GHTF标准，适用于全球。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。
-
FDA Electronic Submission of Lot Distribution Reports Guidance for Industry
Electronic Submission of Lot Distribution Reports 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。
-
FDA CVM GFI #108 Registering with CVM’s Electronic Submission System
CVM GFI #108 Registering with CVM’s Electronic Submission System[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。
-
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。
-
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。
-
FDA Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products
Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products[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。
-
FDA Adverse Accreditation Decisions, SuspensionRevocation of Certificates, or Patient and Physician Notification Orders Draft
Adverse Accreditation Decisions, SuspensionRevocation of Certificates, or Patient and Physician Notification Orders 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。
-
![CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf[网盘链接]](/img/small/20210914103659dm8zg.jpg)
CVM GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf[网盘链接]
GFI #185 (VICH GL43) Target Animal Safety for Veterinary Pharmaceutical Products.pdf是于发布的标准，适用于。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。
-
FDA Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances
Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances[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。
-
FDA Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry
Adaptive Design Clinical Trials for Drugs and Biologics Guidance for Industry[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。
-
FDA Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff
Assay Migration Studies for In Vitro Diagnostic Devices Guidance for Industry and FDA Staff[附网盘链接]是FDA于过去发布的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。
-
FDA Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format
Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products — Content and Format[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。
-
FDA Chronic Hepatitis D Virus Infection Developing Drugs for Treatment Guidance for Industry
Chronic Hepatitis D Virus Infection Developing Drugs for Treatment Guidance for Industry[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。
-
FDA Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels
Converting Units of Measure for Folate, Niacin, and Vitamins A, D, and E on the Nutrition and Supplement Facts Labels[附网盘链接]是Food And Drug Administration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。