List of Drugs for Which Additional Pediatric Information May Produce Health Benefits in the Pediatric Population; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a list entitled ``List of Drugs for Which Additional Pediatric Information May Produce Health Benefits in the Pediatric Population'' (hereinafter referred to as ``the list''). This is a list of approved drugs for which additional pediatric information may produce health benefits in the pediatric population. The list is being published under new statutory requirements of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). The purpose of the list is to identify certain drugs for which certain information is necessary to determine if an approved drug can be used safely and effectively in the pediatric population.