Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Pediatric Information Incorporated Into Human Prescription Drug and Biological Product Labeling." This guidance is intended to assist applicants in determining the appropriate placement and content of pediatric information in human prescription drug and biological product labeling as described in the regulations for the content and format of labeling for human prescription drug and biological products. This guidance finalizes the draft guidance issued on February 28, 2013.