Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling

Providing regulatory submissions in electronic format: content of the risk evaluation and mitigation strategies document using structured product labeling

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
United States. Department of Health and Human Services, issuing body.
United States. Food and Drug Administration, 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, December 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Approval
Risk Evaluation and Mitigation
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
Genre(s):
Technical Report
Abstract:
Under section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379k-1(a)), beginning no earlier than 24 months after the issuance of this final guidance in which the Food and Drug Administration (FDA or Agency) has specified the electronic format for submitting certain submission types to the Agency, the content of such submission types must be submitted electronically and in the format specified by FDA. This guidance describes the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of the FD&C Act. This guidance describes how FDA will implement the requirements for the electronic submission of REMS documents as part of submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and, as described in Section III below, certain biologics license applications (BLAs). Consistent with section 745A(a) of the FD&C Act, beginning 24 months after the issuance of this final guidance, REMS documents must be submitted to FDA in SPL format.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (i, 4 pages)).
NLM Unique ID:
9918250312606676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918250312606676