Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -74
Accepted - Volume 3
Dr. Viking Hedberg
Society for Adolescent Medicine
Comments for FDA General
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.