Guidance for industry : providing regulatory submissions in electronic format, general considerations.

Format Electronic
Publication InfoRockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : Center for Drug Evaluation and Research : Center for Devices and Radiological Health : Center for Food Safety and Applied Nutrition : Center for Veterinary Medicine, [2003]
Description20 p. : digital, PDF file
Supplemental Contenthttps://purl.fdlp.gov/GPO/LPS113040
Subjects
Electronic filing systems--Government policy. --United States.

Other author/creatorCenter for Biologics Evaluation and Research (U.S.)
Other author/creatorCenter for Drug Evaluation and Research (U.S.)
Other author/creatorCenter for Devices and Radiological Health (U.S.)
Other author/creatorCenter for Food Safety and Applied Nutrition (U.S.)
Other author/creatorCenter for Veterinary Medicine (U.S.)
Portion of title Providing regulatory submissions in electronic format, general considerations
General noteTitle from PDF title page (viewed on May 26, 2009).
General note"Draft guidance".
General note"October 2003".
General note"Electronic submissions".
General note"Revision 1".
General noteGPO Cataloging Record Distribution Program (CRDP).
Technical detailsMode of access: Internet at the FDA CBER web site. Address as of 5/26/09: http://www.fda.gov/cber/gdlns/elecgenrev1.pdf ; current access is available via PURL.
GPO item number0499-T-02 (online)
Govt. docs number HE 20.4802:R 26/5/DRAFT

Availability

Library Location Call Number Status Item Actions
Electronic Resources Access Content Online ✔ Available