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Guidance for industry INDs for phase 2 and phase 3 studies, chemistry, manufacturing, and controls information.

Bibliographic Details
Corporate Author:	Center for Drug Evaluation and Research (U.S.)
Format:	Government Document Online Book
Language:	English
Published:	[Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2003]
Subjects:	Medicine, Experimental > Government policy > United States. Drug approval > United States.
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