Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.

Guidance for industry : providing regulatory submissions in electronic format : human pharmaceutical product applications and related submissions using the eCTD specifications.

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Bibliographic Details
Imprint: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]
Description:ii, 16 pages : digital, PDF file
Language:English
Subject:
Center for Drug Evaluation and Research (U.S.)
Drug approval -- United States.
Electronic filing systems -- United States.
Format: E-Resource U.S. Federal Government Document Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/7701633
Hidden Bibliographic Details
Varying Form of Title:Providing regulatory submissions in electronic format
Human pharmaceutical product applications and related submissions using the eCTD specifications
Other authors / contributors:Center for Biologics Evaluation and Research (U.S.)
Notes: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.
GPO item no.:0499-T-02 (online)
Govt.docs classification:HE 20.4802:R 26/3

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