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, April 2017
Language(s):
English
Format:
Text
Subject(s):
Electronic Data Processing -- standards
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.
Genre(s):
Guideline
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (16 pages)).
Edition:
Revision 4
NLM Unique ID:
101704838 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101704838