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.
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Main Text: 3592