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FDA Electronic Submission of IND Safety Reports Technical Conformance Guide Guidance for Industry

蒋千琴 3/22/2022 浏览 312 FDA 美国

标准简介

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。

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Electronic Submission of IND Safety Reports Technical Conformance Guide Guidance for Industry[附网盘链接]
Electronic Submission of IND Safety Reports Technical Conformance Guide Guidance for Industry[附网盘链接](截图)

 

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标准部分原文

Electronic Submission of IND Safety Reports 1

Technical Conformance Guide This document 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 is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for implementing this guidance or send an email to faersesub@fda.hhs.gov. 1. Introduction 1.1 Background This Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic investigational new drug application (IND) safety reports to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). The Guide supplements the draft guidance for industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 2

2019), which implements the electronic submission requirements of section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to electronic submissions for certain IND safety reports submitted to CDER or CBER. 1.2 Purpose This Guide discusses the format for the submission of IND safety reports as required under 21 CFR 312.32(c)(1)(i) as individual case safety reports (ICSRs) to the FDA Adverse Event Reporting System (FAERS). It provides general information for sponsors of commercial and noncommercial INDs pertaining to electronic submission of IND safety reports and attachments in electronic format to FAERS. It also provides information to sponsors on the format for submission of IND safety reports required under 312.32(c)(1) that should not be submitted to 1

This technical specifications document has been prepared by the Office of New Drugs in the Center for Drug Evaluation and Research at the Food and Drug Administration. You may submit comments on this guidance at any time. Submit comments to Docket No. FDA-2017-D-6821 (available at https://www.regulations.gov/docket?D=FDA-2017-D-6821) (see the instructions for submitting comments in the docket). 2

When final, this guidance will represent the FDA’s current thinking on this topic. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-

documents. 1

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