About FDA

Office of Drug Evaluation IV - Personnel

Office of Drug Evaluation IV (in the Office of New Drugs)

Office Organization

Immediate Office

Charles J. Ganley, M.D., (Director)
Vacant (Deputy Director)
Cozette Talib (Project Specialist)
Jagjit Grewal, M.P.H., (Associate Director for Regulatory Affairs)
Merla Matheny, (Lead Administrative Officer - PMAS)
Maryam Baig, (Administrative Officer - PMAS)
Orhan Sulemein, M.S., Ph.D., FAAPM, (Senior Science Policy Analyst)
Pamela Hampton, (Administrative Officer - PMAS)
Susan Johnson, Pharm.D., Ph.D., (Associate Director)

Division of Medical Imaging Products (DMIP)

Libero Marzella, M.D. (Director)
Alex Gorovets, M.D., (Acting Deputy Director)
Ira Krefting, M.D., (Deputy Director for Safety)
Kim Ritenour-Miller, (Regulatory Information Specialist)
Medical Officers
Alex Gorovetz, M.D., (Lead Medical Officer)
Anthony Fotenos, M.D.
Brenda Ye, M.D., (Lead Medical Officer)
Cynthia Welsh, M.D.
Harris Orzach, M.D.
Phillip Davis, M.D.
Qi Feng, M.D.
Scheldon Kress, M.D.
William Dickerson, M.D.

Project Managers

Alberta Davis-Warren, B.S.
Frank Lutterodt, M.S.
James Moore, Pharm.D., M.A.
Kyong (Kaye) Kang, Pharm.D. (Supervisory Consumer Safety Officer)
Modupe Fagbami, M.Ed.
Renee Tyson, MA (Safety Regulatory Project Manager)
Sharon Thomas, BSC, PHIT, CCRP
Thuy Nguyen, M.P.H.


Adebayo Laniyonu, Ph.D. (Supervisory Pharmacologist)
Olayinka Dina, Ph.D.
Richard Fejka,
MS, BCNP (Clinical Analyst, Nuclear Pharmacologist)
Ronald Honchel, Ph.D.
Sally Hargus, Ph.D.
Sunday Awe, Ph.D.
Yanli Ouyang, M.D., Ph.D.
Division of Nonprescription Clinical Evaluation (DNCE)
Theresa Michele, M.D., (Director)
Karen Mahoney, M.D., (Deputy Director)
Betsy Scroggs, Pharm.D., (Associate Director for Labeling)
Wanda Davis (Regulatory Information Specialist)

Social Science Analysts
Barbara Cohen, M.S.
James Stansbury,
Ph.D., M.P.H.  

Pharmacology-Toxicology Reviewers
Cindy Li, Ph.D.
Wafa Harrouk, Ph.D.
Medical Officers
Jane File, M.D., (Lead Medical Officer)
Lucie Yang, M.D., (Lead Medical Officer)
Ryan Raffaelli, M.D.
Project Managers
Alina Salvatore, Pharm.D.
Celia Peacock, R.D., M.P.H.
Dan Brum, Pharm.D., MBA, BCPS, RAC (Supervisory Consumer Safety Officer)
Daniel Reed, M.P.H.
Jade Pham, Pharm.D.
Janice Adams-King, RN, BSN, MS (Safety Regulatory Health Project Manager)
Jeffrey Buchanan
Jung Lee, RPh.
Kristin Hardin, BSN, R.N.
Lara Akinsanya, M.S.
Sherry Stewart, Pharm.D.

Division of Nonprescription Regulation Development (DNRD)
Theresa Michele, M.D., (Director)
Karen Mahoney, M.D., (Deputy Director)
Delores Pinkney, (Regulatory Information Specialist)
Fathia Gibril, M.D., M.HSc, AGAF (Deputy Director for Safety)

Medical Officers
Mona Khurana-Dua, M.D.
Vacant (Lead Medical Officer)
IDS Reviewers
Anita Kumar, Ph.D.
Arlene Solbeck, M.S.
Benjamin Bishop, Pharm D., M.P.H.
Bob Sherman, B.S.
Colleen Rogers, Ph.D., (Team Leader)
Elaine Abraham, R.Ph.
Lydia Velazquez, Pharm.D., (Team Leader)
Michelle Jackson, Ph.D.
Pranvera Ikonomi, PhD.
Steven Adah, Chemist, Ph.D., (Team Leader)
Yoon Kong, Pharm.D.
Division of Pediatric and Maternal Health (DPMH)
Lynne P. Yao M.D. (Acting Associate Director)

Who to contact with questions about Over-the-Counter drugs:
Office of Communications, Division of Drug Information
Toll Free (855) 543-3784, or (301) 796-3400


Page Last Updated: 10/23/2014
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