Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -67

Accepted - Volume 3

Comment Record
Commentor Dr. Mark Charpentier Date/Time 2002-07-08 01:01:20
Organization Indiana School of Medicine
Category Health Professional

Comments for FDA General
5. General Comments The Pediatric Rule is essential to the delivery of healthcare to children. In pediatrics, we are always a step behind research that is typically carried out in adults. As a result new therapies are often delayed. Without a mandate such as the pediatric rule this gap is likely to widen.

EC -67