PEDIATRIC SUBCOMMITTE OF THE
ANTI-INFECTIVE DRUG ADVISORY COMMITTEE
September 11-12, 2000
Briefing Information
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
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
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
*Copyrighted materials may be view at: Dockets Management Branch, HFA-305, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.