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Title Guidance for industry [electronic resource] : M4E, the CTD, efficacy.

Imprint 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]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:C 73/3    ---  Available
Description iii, 58 p. : digital, PDF file
System Details Mode of access via the FDA web site.
Note Title from PDF title page (viewed on July 6, 2009).
"ICH".
"August 2001".
Subject Drug approval -- Government policy -- United States.
Clinical trials -- Reporting -- United States.
Drugs -- Effectiveness -- United States.
Added Author Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
International Conference on Harmonisation.
Added Title M4E, the CTD, efficacy
Gpo Item No. 0499-T (online)
Sudoc No. HE 20.4702:C 73/3

 
    
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