Research Catalog

Title

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

Publication

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]

Details

Additional Authors

Center for Biologics Evaluation and Research (U.S.)

Description

ii, 16 pages : digital, PDF file

Alternative Title

• Providing regulatory submissions in electronic format
• Human pharmaceutical product applications and related submissions using the eCTD specifications

Subject

• Center for Drug Evaluation and Research (U.S.)
• Drug approval > United States
• Electronic filing systems > United States

Note

• Title from PDF title page (viewed on Apr. 23, 2009).
• "June 2008."
• "Revision 2."

System Details (note)

• 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.

Call Number

GPO Internet HE 20.4802:R 26/3

OCLC

marcive319069332

Title

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

Publisher

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]

Type of Content

text

Type of Medium

computer

Type of Carrier

online resource

System Details

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.

Connect to:

https://purl.fdlp.gov/GPO/LPS111798

Added Author

Center for Biologics Evaluation and Research (U.S.)

Gpo Item No.

0499-T-02 (online)

Sudoc No.

HE 20.4802:R 26/3