FDA: Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products—Content and Format

This guidance is intended to assist applicants in preparing the Clinical Pharmacology section of product labeling to meet the requirements of FDA regulations (21 CFR 201.57) and to facilitate communication about this sometimes complicated labeling information. This guidance is also intended to ensure consistency in clinical pharmacology labeling for all prescription drug products approved in CDER and CBER.

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