Electronic submission of IND safety reports: technical conformance guide

Electronic submission of IND safety reports: technical conformance guide

Collection:
Health Policy and Services Research
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, issuing body.
United States. Food and Drug Administration. Office of Medical Products and Tobacco. Oncology Center of Excellence, issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Center for Biologics Evaluation and Research (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, April 2022
Language(s):
English
Format:
Text
Subject(s):
Digital Technology
Drug Approval
Investigational New Drug Application
Safety
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
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). This Guide supplements the draft guidance for industry Providing Regulatory Submissions in Electronic Format: IND Safety Reports (October 2019), which implements the electronic submission requirements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.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (11 pages))
NLM Unique ID:
9918469488206676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918469488206676