Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics Comment Number: EC -74
Accepted - Volume 3
Comment Record
Commentor
Dr. Viking Hedberg
Date/Time
2002-07-08 14:27:50
Organization
Society for Adolescent Medicine
Category
Health Professional
Comments for FDA General
Questions
1. What changes to the pediatric rule, if any, would be necessary to integrate the BPCA and the pediatric rule more effectively?
The pediatric rule needs to be preserved. Pediatric patients need to have new drugs tested, and the pediatric rule is the tool that mandates drug companies to fund testing in pediatric populations.