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Guidance for industry : providing regulatory submissions in electronic format, postmarketing indivudal case safety reports.

Bibliographic Details
Corporate Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.)
Format: Government Document eBook
Language:English
Published: Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2008]
Subjects:
Drug testing > United States > Case studies.
Electronic filing systems > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS111793
Description
Item Description:Title from PDF title page (viewed on Apr. 23, 2009).
"Draft guidance".
"June 2008."
Electronic resource.
Physical Description:8 pages : digital, PDF file.
Format:Mode of access: Internet at the FDA CBER Web site. Address as of 4/23/09: http://www.fda.gov/cber/gdlns/postelect.pdf ; current access is available via PURL.