Guidance for Industry
Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products —Content and Format
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
March 2010
Labeling
open here to see the full-text:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075066.pdf
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