Providing regulatory submissions in electronic format--certain human pharmaceutical product applications and related submissions using the eCTD specifications
- Series Title(s):
- Guidance for industry
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.
- Silver Spring, MD : Center for Drug Evaluation and Research, April 2017
- Automatic Data Processing -- standards Investigational New Drug Application Drug Approval -- legislation & jurisprudence Drug Approval -- organization & administration Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration. United States.
- Guideline Technical Report
- The National Library of Medicine believes this item to be in the public domain. (More information)
- 1 online resource (1 PDF file (16 pages)).
- Revision 4
- NLM Unique ID:
- 101704838 (See catalog record)