A Review of the Experience with Pediatric Written Requests
Issued for Oncology Drug Products
Alemayehu Y. Akalu, PharmD1^, Xi
Meng2^, M.S., Gregory H.
Reaman1,5*, MD, Lian Ma3, Ph.D.,
Weishi Yuan4#, Ph.D., Jingjing
Ye4#*, Ph.D.
1Office of Oncologic Diseases, Office of New Drugs,
Center for Drug Evaluation and Research, Food and Drug Administration,
Silver Spring, MD, USA; 2 Department of Biostatistics,
School of Public Health & Health Sciences, University of
Massachusetts-Amherst; 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, ^co-first author,
*co-corresponding author: Gregory H. Reaman, 10903 New Hampshire Ave,
Silver Spring, MD, 20993. (301)796-0785.
Gregory.Reaman@fda.hhs.gov
; and Jingjing Ye, 8170 Maple Lawn Blvd, Suite 160, Fulton, MD.
(628)239-0505,
jingjingye@gmail.com.
Abstract: 246
Main Text: 3592