Pediatric Subcommittee of the
ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE
June 11, 2002
Slides
Proton-Pump Inhibitor (PPI) Template for Pediatric Written Requests, Hugo E Gallo-Torres, MD, PhD, FDA ppt htm
Pathologic GE Reflux in Children, Age-Related Characteristics: Effect on Design of Clinical Trials, Eric Hassall, MD, BC Children's Hospital/ University of British Columbia ppt htm
Clinical Trial Design Related to Studies of PPIs in Premature and Term Newborns, Mark Hudak, MD, University of Florida at Jacksonville ppt htm
Ethical Issues in Pediatric Research: Placebo Controlled Trials for Gastoesophogeal Reflux, Benjamin Wilfond, MD, National Institutes of Health ppt htm
Another List!!, Rosemary Roberts, MD, FDA pdf
Development of the Preliminary Pharmaceutical Priority List, Dr. William J Rodriguez, FDA ppt htm
Criteria for Developing the Priority List, Dianne Murphy MD, FDA ppt htm
An Introduction to the EU and Its Legislation, Julia Dunne, MD ppt htm
The European Paediatric Initiative, Agnès Saint Raymond, MD, The European Medicines Evaluation Agency ppt htm
CBER Pediatric Assessments Under the 1998 Pediatric Rule ppt htm
OPEN PUBLIC HEARING
Jerry D Gardner, MD, Science for Organizations, Inc. ppt htm
Lithium testing in children: a Public Health Necessity, Martha Hellander, JD, Child & Adolescent Bipolar Foundation ppt htm
Lithium testing in children: a Public Health Necessity, Martha Hellander, JD, Child & Adolescent Bipolar Foundation, Bibliography pdf