Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications

Providing regulatory submissions in electronic format: certain human pharmaceutical product applications and related submissions using the eCTD specifications

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 Biologics Evaluation and Research (U.S.), issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, February 2020
Language(s):
English
Format:
Text
Subject(s):
Drug Approval
Electronic Data Processing
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), at least 24 months after the issuance of a final guidance document in which the Food and Drug Administration (FDA or Agency) has specified the electronic format for submitting submission types to the Agency, such content must be submitted electronically and in the format specified by FDA. This guidance describes how sponsors and applicants must organize the content that they submit to the Agency electronically for all submission types under section 745A(a) of the FD&C Act. This guidance also references several technical specification documents5 and the Electronic Common Technical Document Conformance (eCTD) Guide, which provide additional details regarding the organization of content for electronic submissions.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (17 pages)).
Edition:
Revision 7
NLM Unique ID:
101772607 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101772607