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Guidance for industry : M4S, the CTD, safety.

Bibliographic Details
Corporate Authors: Center for Drug Evaluation and Research (U.S.), Center for Biologics Evaluation and Research (U.S.), 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, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2001]
Subjects:
Drug approval > Government policy > United States.
Clinical trials > Reporting > Government policy > United States.
Online Access:https://purl.fdlp.gov/GPO/LPS114402
Description
Item Description:Title from PDF title page (viewed on July 7, 2009).
"ICH".
"August 2001".
Electronic resource.
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.