A Review of the Experience with Pediatric Written Requests
Issued for Oncology Drug Products
Xi Meng1, M.S., Alemayehu Y. Akalu,
PharmD2, Gregory H. Reaman2,5, MD,
Lian Ma3, Ph.D., Weishi Yuan4,
Ph.D., Jingjing Ye4#, Ph.D.
1 Department of Biostatistics, School of Public Health
& Health Sciences, University of Massachusetts-Amherst;2Office of Oncologic Diseases, Office of New Drugs,
Center for Drug Evaluation and Research, Food and Drug Administration,
Silver Spring, MD, USA; 3 Division of Pharmacometrics
(DPM), Office of Clinical Pharmacology (OCP); 4Division of Biostatistics IX (DBIX), Office of Biostatistics (OB),
Office of Translational Sciences (OTS), Center for Drug Evaluation and
Research (CDER), Food and Drug Administration (FDA); 5Oncology Center of Excellence (OCE), Food and Drug Administration,
Silver Spring, MD, USA
#Completed while work at FDA and corresponding
author: Jingjing Ye, 8170 Maple Lawn Blvd, Suite 160, Fulton, MD.
(628)239-0505,
jingjingye@gmail.com.
Abstract: 285
Main Text: 3585