Docket Management
Docket: 02N-0152 - Timely Pediatric Studies and Adequate Pediatric Labeling for Human Drugs and Biologics
Comment Number: EC -48

Accepted - Volume 1

Comment Record
Commentor Dr. Ellen Clayton Date/Time 2002-07-03 10:38:03
Organization Vanderbilt
Category Health Professional

Comments for FDA General
5. General Comments It is critical that drugs that will be used in children are tested in them. Children are different from adults in many ways that make it difficult or inappropriate to extrapolate data from adults to children. This program is an important incentive to this needed research.

EC -48