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FDA update

 

This guidance is intended to assist applicants in preparing the CLINICAL PHARMACOLOGY 18 section of product labeling to meet regulatory requirements (21 CFR 201.57(c)(13)) and ensure 19 appropriate consistency in the format and content of this section for all prescription drug 20 products approved by FDA.

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM109739.pdf