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Guidance for industry clinical lactation studies; study design, data analysis, and recommendations f

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, [2005] 2005

Guidance for industry clinical studies section of labeling for human prescription drug and biologica

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation, [2006] 2006

Guidance for industry providing regulatory submissions in electronic format, content of labeling.

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, [2005] 2005