Description: Guidance for industry

Other Authors:	Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), International Conference on Harmonisation.
Format:	Electronic
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, [2001]
Physical Description:	ii, 21 pages : digital, PDF file.
Subjects:	Drug approval -- Government policy -- United States. Clinical trials -- Reporting -- Government policy -- United States.
Online Access:	https://purl.fdlp.gov/GPO/LPS114402

Item Description:	Mode of access: Internet at the FDA web site. Address as of 7/7/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129906.pdf ; current access is available via PURL. Title from PDF title page (viewed on July 7, 2009). "ICH". "August 2001". GPO Cataloging Record Distribution Program (CRDP).
Physical Description:	ii, 21 pages : digital, PDF file.
Format:	Mode of access: Internet at the FDA web site. Address as of 7/7/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129906.pdf ; current access is available via PURL.