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)
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
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
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
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.
Division of Nonprescription Drug Products (DNDP)
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
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
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
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Regulatory Information Specialist:
Cindy Mejia, PMAS
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
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
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.
Who to contact with questions about Over-the-Counter drugs:
Toll Free (855) 543-3784, or (301) 796-3400
- For questions about registration and listing of over-the-counter drug products, please visit: Drug Registration and Listing System (DRLS & eDRLS) or email email@example.com.
- For questions about importing over-the-counter drug products, please visit: Importations of Drugs or call 301-796-3301.
- For questions about manufacturing and product quality, please visit http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm095412.htm or call 301-796-3268.
- For questions about over-the-counter product compliance, please visit http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm082757.htm or call 301-796-3110
- CDER Organizational Chart The division that regulates nonprescription drug products is in the Office of Drug Evaluation IV, Office of New Drugs
- CDER Reference Guide (general information, frequently requested phone numbers, CDER officials, and more)
- Department of Health and Human Services Searchable Employee Directory