2005D-0334 Guidance for Industry on the Pediatric Research Equity Act
FDA Comment Number : EC5
Submitter : Mrs. kim salzwedel Date & Time: 11/17/2005 02:11:07
Organization : Mrs. kim salzwedel
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
please require all drugs that could potentially be used on newborns, infants and toddlers to be studied in this population for safety, efficacy, and tollerability.