Abstract: ObjectiveTo study the management pattern ,management model and specification purposes of prescribing information of FDA, giving suggestions for drug regulations in our country. MethodsBy collecting current documents in FDA, analyze drug labeling management. ResultsThe package inserts in the US were administrated in classification with an emphasis on the contents and formats ConclusionOur country should take steps to enforce the management of drug package inserts, revise the regulations to guide drug labeling design, ensure the safety of drug use .

Key words: package insert, prescribing information, management