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Title Guidance for industry [electronic resource] : INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.

Imprint [Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:IN 8/4    ---  Available
Description 1 electronic resource (24 p.)
Note "CMC."
"May 2003."
Bibliography Includes bibliographical references (p. 23-24).
Subject Medicine, Experimental -- Government policy -- United States.
Drug approval -- United States.
Added Author Center for Drug Evaluation and Research (U.S.)
Added Title INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information
Gpo Item No. 0499-T (online)
Sudoc No. HE 20.4702:IN 8/4

 
    
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