U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of Medical Products and Tobacco
  5. Center for Drug Evaluation and Research | CDER
  6. Office of Drug Evaluation IV - Personnel
  1. Center for Drug Evaluation and Research | CDER

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
Nikisha Joyner, Administrative Officer – PMAS
Pamela Hampton, Administrative Officer -PMAS
Wafa Harrouk, PhD - Pharmacologist
Fa-ry Grant, Project Specialist - PMAS
Susan Johnson, PharmD, PhD, Associate Director
Jian Wang, Associate Director for Regulatory Science

Division of Medical Imaging Products (DMIP)

Phone: 301-796-2050

Libero Marzella, MD, PhD, Director
Alex Gorovets, MD, Deputy Director
Ira Krefting, MD, Deputy Director for Safety
Michele Fedowitz, MD, Associate Director for Labeling
Kim Ritenour-Miller, Regulatory Information Specialist
Christina Duarte, Project Specialist

Medical Officers:

Betsy Ballard. MD
Karen Bleich, MD
Stephanie Coquia, MD
Phillip Davis, MD
Qi Feng, MD, PhD
Anthony Fotenos, MD, PhD, Lead Medical Officer
August (Alex) Hofling, MD, PhD
Ira Krefting, MD,Lead Medical Officer
Scheldon Kress, MD
David Lee. MD
Nushin Todd, MD, PhD, Lead Medical Officer
Brenda Ye, MD
Cynthia Welsh, MD

Project Managers:

Kyong (Kaye) Kang, PharmD, Supervisory Consumer Safety Officer
Alberta Davis- Warren, BS
Modupe Fagbami, MEd
Diane Hanner, MPH, MSW
Frank Lutterodt, MS
Thuy Nguyen, MPH
Sulin Sun, PharmD
Lisa Skarupa, RN, MSN,
Sharon Thomas, BS, RHIT, CCRP
Renee Tyson, MA, Safety Regulatory Project Manager

Pharmacologists/Toxicologists:

Adebayo Laniyonu, PhD, Supervisory Pharmacologist
Sunday Awe, PhD
Johnathan Cohen, PhD
Olayinka Dina, PhD
Ronald Honchel, PhD
Yanli Ouyang, MD, PhD

RDRC: Richard Fejka, MS, BCNP, Clinical Analyst, Nuclear Pharmacologist

Health Physicist: Stanley Stern, PhD.

Back to Top

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

Social Science Analysts:

Amanda Pike-McCrudden, MAA
Barbara Cohen, MS 

Pharmacologists - Toxicologists:

Chibueze Ihunnah, PhD.
Donald Thompson, RPh, PhD, DABT
Jane Sohn, PhD, Team Leader
Jennifer White, MPH, PhD
Taro Akiyama, PhD 

Medical Officers:

Dorothy Chang, MD
Edward Chin, MD
Elizabeth Donohoe, MD
Francis Becker, MD, FACP, Lead Medical Officer
Suhail Kasim, MD
Jenny Kelty, MD, Lead Medical Officer
Jody Green, MD, Lead Medical Officer (Acting)
Martha Lenhart, MD
Teresa Podruchny, MD

Project Managers:

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

Back to Top

Regulatory Information Specialist:

Wanda Davis

Project Specialist:

Cindy Mejia, PMAS

IDS Reviewers:

Anita Kumar, PhD
Arlene Solbeck, MS
Benjamin Bishop, PharmD, MPH
Francisco Matinez-Murillo, PhD., Team Leader
Brandon McClary, BS, PhD
Hana Mujahid, PhD
Karen Livornese, MSN
Keisha M. Findley, PhD
Kevin Lorick, PhD., Team Leader
Lori N. Parsons, Ph.D.
Michelle Jackson, PhD
Michelle Walker, PhD
Pranvera Ikonomi, PhD
Robert Bahde, PhD
Sergio Coelho, PhD
Steven Adah, PhD, Team Leader
Yoon Kong, PharmD

Back to Top

Division of Pediatric and Maternal Health (DPMH)

Lynne P. Yao M.D., Director
John Alexander, Deputy Director
Tammie Brent Howard, RN, MSN, Senior Clinical Advisor
Michael Smith, Administrative Specialist

Kids and Regulatory Affairs Team Members (KARATS)

Rosemary Addy, M.H.S., Supervisory Consumer Safety Officer
George Greeley, M.S., CSO Team Leader, Regulatory Health Project Manager
Gettie Audain, Regulatory Health Project Manager
Matt Bacho, Regulatory Health Project Manager
Maria Dobbs, Regulatory Information Specialist
Lori Gorski,  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
Shelly Wells, Regulatory Information Specialist 
Millie Wright, Regulatory Health Project Manager
Jacquline Yancy, Regulatory Health Project Manager

Back to Top

Maternal Health Team Members

Tamara Johnson, M.D., M.S., Team Leader
Miriam Dinatale, D.O., L.C.D.R., U.S.P.H.S., M.D., Team Leader
Kristie Baisden, M.D.
Carrie Ceresa, Clinical Analyst
Jane Liedtka, M.D.
Christos Mastroyannis, M.D.
Erica Radden (MHT Consults), M.D.
Catherine Roca, 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
Mona Khurana, M.D., Team Leader
Beth Dumowicz, M.D.
Ethan Hausman, M.D.
Yeruck (Lily) Mulugeta, M.D.
Erica Radden, M.D.
Jacqueline Spaulding, M.D.
Amy Taylor, M.D., M.H.S.
Carolyn Yancey, M.D. 

Back to Top

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

Back to Top