Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -62
Accepted - Volume 3

Comment Record
Commentor Dr. Thomas Rand Date/Time 2002-07-05 23:24:14
Organization St. Luke' s Children's Hospital
Category Individual

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? My experience as a pediatric specialist leads me to the opinion that the pediatric rule should be retained and not weakened. The pediatric rule is not replaced by the Best Pharmaceuticals act; both are necessary to provide incentives and requirements to adequately test therapies in children




EC -62