PEDIATRIC SUBCOMMITTE OF THE
ANTI-INFECTIVE DRUG ADVISORY COMMITTEE
September 11-12, 2000
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
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.