AdvaMed Annual Submissions Workshop In Brief
This article was originally published in The Gray Sheet
Executive Summary
Pediatric working group: Nominations are solicited for a CDRH team to facilitate pediatric premarket review consultations, coordinate activities and keep FDA's Office of Pediatric Therapeutics informed of device-related issues, Associate Director of Clinical Research & Government Affairs Joanne Less tells AdvaMed submissions workshop attendees in Arlington, Va. May 24. One staffer from each Office of Device Evaluation review branch, two from the Office of In Vitro Diagnostic Device Evaluation & Safety, and one from each of the other CDRH offices will be represented on the team...