Guidance for industry : M4E, the CTD, efficacy.

Bibliographic Details
Corporate Authors:	Center for Drug Evaluation and Research (U.S.) Center for Biologics Evaluation and Research (U.S.) International Conference on Harmonisation
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 > United States. Drugs > Effectiveness > United States.
Online Access:	Connect to online resource - All users (Federal Depository Library Program Persistant URL)
Physical Description:	iii, 58 pages : digital, PDF file
Variant Title:	M4E, the CTD, efficacy
Format:	Government Document Electronic Conference Proceeding eBook

Description
Note:	Title from PDF title page (viewed on July 6, 2009). "ICH". "August 2001". Electronic resource.
Call Number:	HE 20.4702:C 73/3
System Details:	Mode of access: Internet at the FDA web site. Address as of 7/6/09: http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129865.pdf ; current access is available via PURL.