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Guidance for industry and review staff labeling for human prescription drug and biological products

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research ; Rockville, MD : Center for Biologics Evaluation and Research , [2009] 2009

Guidance for industry content and format for geriatric 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, [2001] 2001

Guidance for industry hypertension indication, drug labeling for cardiovascular outcome claims.

Silver Spring, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2008] 2008

Guidance for industry indexing structured product 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, [2008] 2008

Guidance for industry providing regulatory submissions in electronic format, drug establishment regi

Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, [2008] 2008