FDA Guidance on Clinical Pharmacology Section of Drug and Biological Product Labeling

• By: Staff Editor
• Date: January 30, 2017
• Source: http://www.fda.gov

FDA Guidance on Clinical Pharmacology Section of Drug and Biological Product Labeling

The clinical pharmacology section of the label should provide an information that is understandable and clear to health care professionals who may not have specific expertise in clinical pharmacology. The FDA guidance offers recommendations for preparing the clinical pharmacology section of prescription drug labeling for applicants submitting NDAs, supplements to approved NDAs, ANDAs, biologics license applications (BLAs) and supplements to BLAs.

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