Pediatric drug list inclusion via petition process will get expedited review -- FDA.
This article was originally published in The Tan Sheet
Executive Summary
PEDIATRIC DRUG LIST INCLUSION THROUGH CITIZEN PETITION PROCESS will receive expedited consideration at FDA, Office of Chief Counsel attorney Elizabeth Dickinson told the Drug Information Association annual meeting in Boston June 10. "These petitions are identified as pediatric citizen's petitions. They will go through a special process. Generally they will get the thumbs-up, thumbs-down approach," she said.