PEDIATRIC SUBCOMMITTE OF THE

ANTI-INFECTIVE DRUG ADVISORY COMMITTEE

September 11-12, 2000

Briefing Information

Cover Letter

Draft Agenda

Temple, Robert, "Problems in Interpreting Active Control Equivalence Trials," Accountabilityin Research, Vol. 4, pp. 267-275.*

Temple, Robert "Difficulties in Evaluating Positive Control Trials," Biopharmaceutical Section Proceedings of the American Statistical Association, 1983.*

Federal Register notice "International Conference on Harmonisation; Choice of Control Group in Clinical Trials,"  64FR51767 9/24/99. pdf txt

Zito, Julie Magno, et al "Trends in the Prescribing of Psychotropic Medications to Preschoolers," JAMA vol 283, no. 8, February 23, 2000

First Lady Hillary Rodham Clinton Launches New Public-Private Effort to Improve the Diagnosis and Treatment of Children with Emotional and Behavioral Conditions, March 20, 2000

Pediatric Cancer Therapeutics: Letter of Interest, February 11, 2000

Pediatric Oncology: Written Request and Exclusivity Determinations, April 14, 2000

September 11, 2000

Ethics of Placebo-controlled Trials in Children

Briefing Information

References

Tab 3 From the FDA, "Sample Written Request for Oral Antihypertensives" pdf

Tab 4 From the FDA, "Sample Written Request for Antidepressants" pdf

Additional Briefing Information

Tab 5 International Conference on Harmonization (ICH) Guidance entitled, "E10, Choice of Control Group in Clinical Trials"

Tab 6 International Conference on Harmonization (ICH) Guidance entitled, "E11, Clinical Investigation of Medicinal Products in the Paediatric Population"

*Copyrighted materials may be view at:  Dockets Management Branch, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.