Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications
Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research, [2008]
Physical Details
ii, 16 pages : digital, PDF file
data file
OCLC
ocn319069332
Title from PDF title page (viewed on Apr. 23, 2009).
"June 2008."
"Revision 2."
Mode of access: Internet at the FDA CBER Web site. Address as of 4/23/09: http://www.fda.gov/cber/gdlns/esubapp.pdf ; current access is available via PURL.