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
Lesley Furlong, MD, Deputy Director
Jagjit Grewal, MPH, Associate Director for Regulatory Affairs
Merla Matheny, Lead Administrative Officer - PMAS
Maryam Baig, Administrative Officer - PMAS
Nakisha Joyner, Administrative Officer – PMAS
Pamela Hampton, 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
Christina Duarte, Administrative Assistant
 

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

Pharmacologists/Toxicologists:

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
Valerie Pratt, MD, Deputy Director for Safety
Dalmas Robinson, Administrative Support Assistant (PMAS)
 

Social Science Analysts:

Amanda Pike-McCrudden, MAA
Barbara Cohen, MS 

Pharmacologists - Toxicologists:

Donald Thompson, RPh, PhD, DABT
Jane Sohn, PhD, Team Leader
Jennifer White, MPH, PhD
Wafa Harrouk, PhD

Medical Officers:

Brenda Gierhart, MD
Elizabeth Donohoe, MD
Francis Becker, MD, FACP, Lead Medical Officer
Jane Filie, MD, Lead Medical Officer
Jenny Kelty, MD
Ketan Parikh, MD
Ryan Raffaelli, MD
Steve Osborne, MD, Lead Medical Officer
Teresa Podruchny, MD

Project Managers:

Janice Adams-King, RN, BSN, MS, Safety Regulatory Health Project Manager
Lara Akinsanya, MS
Dan Brum, PharmD, MBA, BCPS, RAC, Supervisory Consumer Safety Officer
Kristen Hardin, BSN, RN
Jung Lee, RPh
Celia Peacock, RD, MPH
Jade Pham, PharmD
Daniel Reed, MPH
Alina Salvatore, PharmD
Tinya Sensie, MHA
Sherry Stewart, PharmD
 

Regulatory Information Specialists:

Delores Pinkney
Wanda Davis

IDS Reviewers:

Anita Kumar, PhD
Arlene Solbeck, MS
Benjamin Bishop, PharmD, MPH
Bob Sherman, BS
Diego Rua, PhD, MBA
Elaine Abraham, RPh
Francisco Matinez-Murillo, PhD., Team Leader
Karen Livornese, MSN
Kevin Lorick, PhD., Team Leader
Lydia Velazquez, PharmD,
Michelle Jackson, PhD
Michelle Walker, PhD
Pranvera Ikonomi, PhD
Sergio Coelho, PhD
Steven Adah, PhD, Team Leader
Yoon Kong, PharmD
    

Division of Pediatric and Maternal Health (DPMH)

Lynne P. Yao M.D.,  Director
Vacant Associate Director, Labeling
John Alexander, Deputy Director (detail)
Melissa Tassinari, Ph.D., D.A.B.T., Senior Clinical Advisor
Shelly Wells, Regulatory Information Specialist

Kids and Regulatory Affairs Team Members (KARATS)

Rosemary Addy, M.H.S.,Supervisory Consumer Safety Officer
Gettie Audain, Regulatory Health Project Manager

Matt Bacho,  Regulatory Health Project Manager
Maria Dobbs, Regulatory Information Specialist
Lori Gorski,  Regulatory Health Project Manager
George Greeley, M.S., Regulatory Health Project Manager
Kerri-Ann Jennings, Regulatory Health Project Manager
Denise Johnson-Lyles, Regulatory Health Project Manager
Meshaun Payne, Regulatory Health Project Manager
Denise Pica-Branco, Ph.D., Regulatory Health Project Manager
Millie Wright, Regulatory Health Project Manager
 

Maternal Health Team Members

Tamara Johnson, M.D., M.S., Maternal Health Team Leader 
Vacant Clinical Analyst
Miriam Dinatale, D.O., L.C.D.R., U.S.P.H.S.
Carol Kasten, M.D.
Christos Mastroyannis, M.D.
Leyla Sahin, M.D., F.A.C.O.G.

Pediatric Team Members


Hari Cheryl Sachs, M.D., Lead Medical Officer, Pediatrics Team Leader
Ethan Hausman , M.D.
Mona Khurana, M.D.
Erica Radden, M.D.
Donna Snyder, M.D.
Amy Taylor, M.D., M.H.S.
 

 

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
druginfo@fda.hhs.gov

 

 

 

Page Last Updated: 07/11/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.