Post-approval safety data management : definitions and standards for expedited reporting.

Bibliographic Details
Corporate Authors:	United States. Food and Drug Administration, International Conference on Harmonisation
Format:	Government Document Conference Proceeding eBook
Language:	English
Published:	[Rockville, Md.] : [U.S. Dept. of Health and Human Services, Food and Drug Administration], [2003]
Subjects:	Drugs > Side effects > Reporting. Clinical pharmacology.
Online Access:	https://purl.fdlp.gov/GPO/LPS113940

Description
Item Description:	Title from PDF title page (viewed on June 19, 2009). "ICH harmonised tripartite guideline draft". "Recommended for adoption at step 2 of the ICH process on July 19, 2003 by the ICH Steering Committee". "ICH E2E ver. 3.8". Electronic resource.
Physical Description:	12 : digital, PDF file.
Format:	Mode of access: Internet at the FDA web site. Address as of 6/19/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm129458.pdf ; current access is available via PURL.