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


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, (Technical Information Specialist)
Crystal Coulter, (Program Specialist - PMAS)
 

Medical Officers
Alex Gorovetz, M.D., (Lead Medical Officer)
Brenda Ye, M.D., (Lead Medical Officer)
Phillip Davis, M.D.
Qi Feng, M.D.
Scheldon Kress, M.D.
Barbara Stinson, M.D.
Cynthia Welsh, M.D.
William Dickerson, M.D.

Project Managers
Kyong (Kaye) Kang, (Supervisory Consumer Safety Officer)
Renee Tyson, (Safety Regulatory Project Manager)
Alberta Davis-Warren, (Regulatory Project Manager)
Frank Lutterodt, (Regulatory Project Manager)
James Moore, (Regulatory Health Project Manager)
Thuy Nguyen, (Regulatory Health Project Manager)
Sharon Thomas, (Regulatory Project Manager)
 

Pharmacologists/Toxicologists
Adebayo Laniyonu, (Supervisory Pharmacologist)
Sunday Awe, (Pharmacologist)
Olayinka Dina, (Pharmacologist)
Richard Fejka, (Clinical Analyst, Nuclear Pharmacologist)
Sally Hargus, (Toxicologist)
Ronald Honchel, (Toxicologist)
Yanli Ouyang, (Toxicologist)


Division of Nonprescription Clinical Evaluation (DNCE)

Theresa Michele, M.D.,  (Director)
Vacant (Deputy Director)
Wanda Davis (Regulatory Information Specialist)
Vacant (Technical Information Assistant)
Robert Dorsam, Ph.D., (Pharmacology-Toxicology Reviewer)
Wafa Harrouk, Ph.D., (Pharmacology-Toxicology Reviewer)
Cindy Li, Ph.D., (Pharmacology-Toxicology Reviewer)
Barbara Cohen, M.S., (Social Science Analyst)
James Stansbury, (Social Science Analyst)  

Medical Officers
Lucie Yang, M.D., (Lead Medical Officer)
Jane File, M.D., (Acting Lead Medical Officer)
Linda Hu, M.D.
Steven Osborne, M.D.
Ryan Raffaelli, M.D.

Project Managers
Dan Brum, Pharm.D., MBA, BCPS, RAC (Supervisory Consumer Safety Officer)
Jeffrey Buchanan, (Regulatory Health Project Manager)
Kristin Hardin, Pharm. D. (Regulatory Health Project Manager)
Jung Lee, Pharm.D., (Regulatory Health Project Manager)
Celia Peacock, R.D., M.P.H., (Regulatory Health Project Manager)
Jade Pham, Pharm.D., (Regulatory Health Project Manager)
Daniel Reed, M.P.H. (Regulatory Health Project Manager)
Alina Salvatore, Pharm.D., (Regulatory Health Project Manager)
Sherry Stewart, Pharm.D., (Regulatory Health Project Manager)


Division of Nonprescription Regulation Development (DNRD)

Theresa Michele, M.D., (Acting Director)
Fathia Gibril, M.D., M.HSc, AGAF (Deputy Director for Safety)
Janice Adams-King, RN, BSN, MS (Safety Regulatory Health Project Manager)
Delores Pinkney, (Regulatory Information Specialist)
Vacant (Writer Editor)

Medical Officers
Narayan Nair, M.D., (Lead Medical Officer)
Mona Khurana-Dua, M.D.

Team 1
Steven Adah, Chemist, Ph.D., (Team Leader)
Elaine Abraham, R.Ph., (IDS Reviewer)
Ayana Rowley, Pharm.D., (IDS Reviewer)

Team 2
Lydia Velazquez, Pharm.D., (Team Leader)
Yoon Kong, Pharm.D., (IDS Reviewer)
Arlene Solbeck, M.S., (IDS Reviewer)
Benjamin Bishop, Pharm D., M.P.H., (IDS Reviewer)
 

Team 3
Colleen Rogers, Ph.D., (Team Leader)
Michelle Jackson, Ph.D., (IDS Reviewer)
Anita Kumar, Ph.D., (IDS Reviewer)
Bob Sherman, B.S., (IDS Reviewer)
Pranvera Ikonomi, (IDS Reviewer)

Team 4
Betsy Scroggs, Pharm.D., (Team Leader)
Mary Vienna, R.N., (IDS Reviewer)

    • Who to contact with questions about OTC drugs:
Marketed under OTC Monographs (All Categories)Marketed or proposed for marketing under an NDA

Dan Brum 301-796-0578
dan.brum@fda.hhs.gov

 Dan Brum 301-796-0578
dan.brum@fda.hhs.gov