Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice

Guidance for Industry: Pediatric Information Incorporated Into Human Prescription Drug and Biological Products Labeling Good Review Practice (PDF - 269KB)

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http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM341394.pdf?source=govdelivery