About FDA

Office of Drug Evaluation IV - Personnel

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

Office Organization

Immediate Office (ODE IV):

Phone: 301-796-2060 Fax: 301-796-9899

Charles J. Ganley, MD, Director
Vacant, Deputy Director
Cozette Talib, Project Specialist
Jagjit Grewal, MPH, Associate Director for Regulatory Affairs
Merla Matheny, Lead Administrative Officer - PMAS
Maryam Baig, Administrative Officer - PMAS
Susan Johnson, PharmD, PhD, Associate Director

Division of Medical Imaging Products (DMIP)

Phone: 301-796-2050

Libero Marzella, MD, Director
Alex Gorovets, MD, Acting Deputy Director
Ira Krefting, MD, Deputy Director for Safety
Kim Ritenour-Miller, Regulatory Information Specialist

Medical Officers:

Alex Gorovetz, MD, Lead Medical Officer
Anthony Fotenos, MD
Brenda Ye, MD, Lead Medical Officer
Cynthia Welsh, MD
Harris Orzach, MD
Phillip Davis, MD
Qi Feng, MD
Scheldon Kress, MD
William Dickerson, MD

Project Managers:

Kyong (Kaye) Kang, PharmD, Supervisory Consumer Safety Officer
Alberta Davis- Warren, BS
Frank Lutterodt, MS
James Moore, PharmD, MA
Modupe Fagbami, MEd
Renee Tyson, MA, Safety Regulatory Project Manager
Sharon Thomas, BSC, PHIT, CCRP
Thuy Nguyen, MPH


Adebayo Laniyonu, PhD, Supervisory Pharmacologist
Olayinka Dina, PhD
Richard Fejka, MS, BCNP, Clinical Analyst, Nuclear Pharmacologist
Ronald Honchel, PhD
Sally Hargus, PhD
Sunday Awe, PhD
Yanli Ouyang, MD, PhD

Division of Nonprescription Drug Products (DNDP)

Phone: 301-796-2080

Theresa Michele, MD, Director
Karen Mahoney, MD, Deputy Director
Betsy Scroggs, PharmD, Associate Director for Labeling
Vacant, Deputy Director for Safety

Social Science Analysts:

Barbara Cohen, MS
James Stansbury, PhD, MPH

Pharmacology-Toxicology Reviewers:

Cindy Li, PhD
Wafa Harrouk, PhD

Medical Officers:

Elizabeth Donohoe, MD
Francis Becker, MD, FACP, Lead Medical Officer
Jane File, MD, Lead Medical Officer
Mona Khurana-Dua, MD
Ryan Raffaelli, MD
Teresa Podruchny, MD

Project Managers:

Dan Brum, PharmD, MBA, BCPS, RAC, Supervisory Consumer Safety Officer
Delores Pinkney, Regulatory Information Specialist
Wanda Davis, Regulatory Information Specialist
Alina Salvatore, PharmD
Celia Peacock, RD, MPH
Daniel Reed, MPH
Jade Pham, PharmD
Janice Adams-King, RN, BSN, MS, Safety Regulatory Health Project Manager
Jeffrey Buchanan
Jung Lee, RPh
Kristen Hardin, BSN, RN
Lara Akinsanya, MS
Sherry Stewart, PharmD

IDS Reviewers:

Anita Kumar, PhD
Arlene Solbeck, MS
Benjamin Bishop, PharmD, MPH
Bob Sherman, BS
Colleen Rogers, PhD, Team Leader
Diego Rua, PhD, MBA
Elaine Abraham, RPh
Lydia Velazquez, PharmD, Team Leader
Michelle Jackson, PhD
Michelle Walker, PhD
Pranvera Ikonomi, PhD
Sergio Coelho, PhD
Steven Adah, Chemist, PhD, Team Leader
Yoon Kong, PharmD  

Division of Pediatric and Maternal Health (DPMH)

Lynne P. Yao M.D., Acting Director
Rosemary Addy, M.H.S.,Supervisory Consumer Safety Officer
Jeanine Best, M.S.N., R.N., P.N.P., Acting Associate Director, Labeling
Jane Inglese, Ph.D., J.D., Team Leader
Tamara Johnson, M.D., M.S., Maternal Health Team Leader
Alyson Karesh, M.D., Pediatrics Team Leader
Hari Cheryl Sachs, M.D., Lead Medical Officer, Pediatrics Team Leader
Melissa Tassinari, Ph.D., D.A.B.T., Senior Clinical Advisor
Shelly Wells, Regulatory Information Specialist

Kids and Regulatory Affairs Team Members (KARATS)

Matt Bacho, Sr. Regulatory Health Project Manager
Maria Dobbs, Regulatory Information Specialist
Lori Gorski, Sr. Regulatory Health Project Manager
George Greeley, M.S., Sr. Regulatory Health Project Manager
Denise Pica-Branco, Ph.D., Sr. Regulatory Health Project Manager
Millie Wright, Sr. Regulatory Health Project Manager

Maternal Health Team Members

Carrie Ceresa, Pharm.D., M.P.H., Clinical Analyst
Miriam Dinatale, D.O., L.C.D.R., U.S.P.H.S.
Carol Kasten, M.D.
Leyla Sahin, M.D., F.A.C.O.G.

Pediatric Team Members

Ethan Hausman , M.D.
Erica Radden, M.D.
Donna Snyder, M.D.
Amy Taylor, M.D., M.H.S.
Erica Wynn, M.D., M.P.H.


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: 04/08/2015
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