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Title Guidance for industry [electronic resource] : integrated summary of effectiveness.

Imprint Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) ; Rockville, MD : Center for Biologics Evaluation and Research (CBER), [2008]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:EF 3    ---  Available
Description 13 p. : digital, PDF file
System Details Mode of access via the FDA CDER web site.
Note Title from PDF title page (viewed on Apr. 9, 2009).
"Procedural."
"Draft guidance"--PDF cover.
"August 2008."
Bibliography Includes bibliographical references (p. 13).
Subject Drugs -- Effectiveness.
Biologicals -- Effectiveness.
Added Author Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Added Title Integrated summary of effectiveness
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:EF 3

 
    
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