CBER: Center for Biologics Evaluation and Research (FDA) | CDER: Center for Drug Evaluation and Research (FDA) | CDRH: Center for Devices and Radiological Health (FDA) | CFSAN: Center for Food Safety and Applied Nutrition (FDA)
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Center for Biologics Evaluation and Research (CBER) Div. of FDA
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CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.
CBER’s mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies.
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OFFICE OF THE CENTER DIRECTOR
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Karen Midthun, MD – (Acting) Director and Deputy Director
301-827-0372 / fax 301-827-0440
‘Dr. Midthun is the Acting Director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.
Dr. Midthun and center staff are committed to facilitating the development of biological products and providing oversight throughout the product life cycle. Examples of these activities include
* reviewing and providing advice during product development
* conducting research that supports product development
* evaluating applications and making approval decisions based on safety and effectiveness data
* monitoring the safety of biological products
“Biological products touch people’s lives on a daily basis with over 200 million vaccinations, 29 million transfusions of blood and blood components, and 1.6 million musculoskeletal tissue transplants each year,” says Dr. Midthun. “Many of the products we regulate are vital for the public health, such as pandemic influenza vaccines and life-saving blood products. I’m proud to lead a team whose efforts help the timely development of safe and effective products to meet these needs.”
Dr. Midthun previously served as the deputy director of CBER and the director of the Office of Vaccines Research and Review within CBER.
Before joining FDA in 1993, Dr. Midthun was on the faculty of the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of investigational vaccines and was an attending physician at the Johns Hopkins Hospital.
Dr. Midthun received her bachelor’s degree from the Massachusetts Institute of Technology and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases. She is a fellow of the Infectious Diseases Society of America and a member of the American College of Physicians and the American Society for Virology.
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Anne E. Wilcox – Special Assistant
301-827-0372
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David S. Cho, Ph.D – Senior Scientist for Emerging & Pandemic Threat Preparedness
301-827-6352 / fax 301-827-0440
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Sheryl L. Lard-Whiteford, PhD – Associate Director for Quality Assurance
301-827-0379
fax 301-827-2920
fax 301-827-2920
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Diane Maloney, JD – Associate Director for Policy
301-827-0372
fax 301-827-0440
fax 301-827-0440
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Laura A. Rich, JD – Regulations and Policy Staff
301-827-6219
fax 301-827-3093
fax 301-827-3093
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Carolyn A. Wilson, PhD – Associate Director for Research
301-827-0481
fax 301-827-3187
fax 301-827-3187
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Nga Yen Nguyen, PhD – Core Facilities Team
301-402-4996
fax 435-2231
fax 435-2231
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Robert A. Yetter, PhD – Associate Director for Review Management
301-827-0373
fax 301-827-9434
fax 301-827-9434
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Jules M. Meisler – Document Control Center
301-827-5940
fax 301-594-0149
fax 301-594-0149
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Christopher C. Joneckis, PhD – Senior Advisor for Chemistry, Manufacturing, & Control
301-435-5681
fax 301-827-9434
fax 301-827-9434
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Joan Wilmarth Blair – Senior Advisor for International Affairs
301-827-0639
fax 301-827-0440
fax 301-827-0440
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Cynthia L. Kelley, MS – Senior Advisor for Counterterrorism/Medical Countermeasures
301-827-0636
fax 301-827-0440
fax 301-827-0440
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Richard D. Diamond, MD, MPA – Special Assistant to the Director for Human Subject Protection
301-496-1864
fax 301-827-0440
fax 301-827-0440
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(Vacant) – Emergency Response Coordinator
301-827-0372
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Marc Kusinitz, PhD – Science Communications Advisor
301-827-0372
fax 301-827-0440
fax 301-827-0440
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(Vacant) – Associate Director for Medicine
301-827-0372
fax 301-827-0440
fax 301-827-0440
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OFFICE OF BIOSTATISTICS AND EPIDEMIOLOGY
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Robert Ball, MD, MPH – DIRECTOR
301-827-3034
fax 301-827-0648
fax 301-827-0648
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Steven A. Anderson, PhD – Deputy Director & Associate Director for Research
301-827-3034
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Mark O. Walderhaug, PhD – Associate Director for Risk Assessment
301-827-3034
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Jawahar Tiwari, PhD – Associate Director for Regulatory Policy
301-827-3034
fax 301-827-0648
fax 301-827-0648
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Division of Biostatistics
Henry S. Hsu, PhD, MPH
301-827-3977
fax 301-827-5218
fax 301-827-5218
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A. Dale Horne, DrPH – Vaccine Evaluation Branch
301-827-3977
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Ghanshyam Gupta, PhD – Therapeutics Evaluation Branch
301-827-3977
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Division of Epidemiology
Rickey Wilson, MD, JD
301-827-3974
fax 301-827-5218
fax 301-827-5218
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Robert P. Wise, MD, MPH – Deputy Division Director & (Acting) Therapeutics and Blood Safety Branch
301-827-3974
fax 301-827-5218
fax 301-827-5218
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Andrea R. Sutherland, MD, MSc, MPH – Vaccine Safety Branch
301-827-3974
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Hector S. Izurieta, MPH – Analytic Epidemiology Branch
301-827-3974
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OFFICE OF COMMUNICATION, OUTREACH AND DEVELOPMENT
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Lorrie H. McNeill – DIRECTOR
301-827-2000
fax 301-827-3843
fax 301-827-3843
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Joanne C. Binkley – Deputy Director
301-827-2000
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Division of Manufacturers Assistance and Training
Leslie D. Wheelock
301-827-2000
fax 301-827-3079
fax 301-827-3079
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Donna L. Lipscomb – Career Development and Directed Training Branch
301-827-2000
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Cynthia P. Whitmarsh – Manufacturers Assistance & Technical Training Branch
301-827-2000
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Division of Disclosure and Oversight Management
Susan C. Frantz-Bohn
301-827-2000
fax 301-827-3843
fax 301-827-3843
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Matthew D. Lyons – Congressional and Oversight Branch
301-827-2000
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Beth Brockner-Ryan – Access Litigation & Freedom of Information Branch
301-827-2000
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Division of Communication and Consumer Affairs
Diane Bartell
301-827-2000
fax 301-827-3843
fax 301-827-3843
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Joan C. Hawkins (Acting) – Communication Technology Branch
301-827-2000
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Walter Gardner – Consumer Affairs Branch
301-827-2000
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OFFICE OF MANAGEMENT
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James M. Sigg – DIRECTOR
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Deirdre P. Hussey – Deputy Director
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Ann M. Jenkins – Special Assistant
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Jeffrey M. Anderson – Regulatory Information Management Staff
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Maureen E. Sheridan – White Oak Planning Team
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Lisa M. Durphy – Strategic Human Capital Programs
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Division of Program Services
David R. Leffler
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Sarath Seneviratne – Assistant Director for Safety
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Catrina M. Posley – Building Operations Staff
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Cynthia A. Hart-Smith – Program Operations Branch
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Marsha C. Williams – Program Management Services Branch
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Division of Planning, Evaluation, & Budget
Karen M. O’Brien
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Connie Giganti – Resource Management Branch
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Mary Pat Leary – Planning & Evaluation Branch
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Division of Scientific Advisors & Consultants
William Freas, PhD
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Division of Veterinary Services
Philip J. Snoy, DVM
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OFFICE OF INFORMATION TECHNOLOGY
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Ginger Leo – DIRECTOR
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Amy El Naggar – Deputy Director & Division of Information Operations
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Division of Information Development
Nadia O. Davey
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OFFICE OF BLOOD RESEARCH AND REVIEW
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Jay S. Epstein, MD – DIRECTOR
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Ginette Y. Michaud, MD – Deputy Director for Medical and Scientific Affairs
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Basil Golding, MD (Acting) – Associate Director for Medical and Scientific Affairs
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Mark J. Weinstein, PhD – Senior Advisor for Scientific Affairs
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Alan E. Williams, PhD – Associate Director for Regulatory Affairs
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Chintamani D. Atreya, PhD – Associate Director for Research
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Jennifer B. Scharpf, MPH – Associate Director for Policy and Communications
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Sayah Nedjar, Ph.D. – Deputy Associate Director for Regulatory Affairs
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Toby Silverman, MD – Senior Advisor for Medical Affairs
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Linda M. Alms – Special Assistant to the Director
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Division of Emerging & Transfusion Transmitted Diseases – I.O.D.
Hira L. Nakhasi, PhD
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Paul A. Mied, PhD – Deputy Director
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Robin M. Biswas, MD – Product Testing Staff
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Elliot P. Cowan, PhD – Product Review Branch
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David Asher, MD – Laboratory of Bacterial, Parasitic, & Unconventional Agents
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Indira K. Hewlett, PhD – Laboratory of Molecular Virology
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Gerardo Kaplan, PhD – Laboratory of Hepatitis & Related Emerging Agents
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Division of Hematology
(Vacant)
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Mahmood Farshid, MD – Deputy Director
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Susan L. Abbondanzo, MD – Deputy Director of Operations
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Jaroslav G. Vostal, MD, PhD – Laboratory of Cellular Hematology
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Timothy K. Lee, PhD (Acting) – Laboratory of Hemostasis
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Dorothy E. Scott, MD – Laboratory of Plasma Derivatives
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Nisha Jain, MD, PhD – Clinical Review Branch
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Abdu Alayash, PhD – Laboratory of Biochemistry and Vascular Biology
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Division of Blood Applications
Richard J. Davey, MD
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Sheryl A. Kochman – Deputy Director
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Leslie G. Holness, MD – Blood and Plasma Branch
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(Vacant) – Regulatory Project Management Branch
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Teresita C. Mercado – Devices Review Branch
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OFFICE OF VACCINES RESEARCH AND REVIEW
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Norman W. Baylor, PhD – DIRECTOR
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Marion F. Gruber, PhD – Deputy Director
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Konstantin Chumakov, Ph.D. – Associate Director for Research
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Erik A. Henchal, Ph.D. – Associate Director, Management & Scientific Affairs
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Theresa M. Finn, Ph.D. – Associate Director for Regulatory Policy
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Philip R. Krause, MD. (Acting) – Associate Director for Medical Policy and Vaccine Safety
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Maureen A. Hess, MPH – Special Assistant for Communication
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Linda H. Shone – Special Assistant
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Division of Product Quality
William M. McCormick, Ph.D.
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Rajesh K. Gupta, Ph.D. – Deputy Director & (Acting) Product Quality Laboratory Staff
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(Vacant) – Quality Assurance Staff
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Lokesh Bhattacharyya, PhD – Validation Staff
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Division of Viral Products
Jerry P. Weir, PhD
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Robin Levis, PhD (Acting) – Deputy Director
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Stephen M. Feinstone, MD – Laboratory of Hepatitis Viruses
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Lewis J. Markoff, MD – Laboratory of Vector Borne Diseases
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Hana Golding, PhD – Laboratory of Retroviruses
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Andrew M. Lewis, MD – Laboratory of DNA Viruses
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Jerry P. Weir, PhD (Acting) – Laboratory of Pediatric & Respiratory Viral Diseases
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Konstantin M. Chumakov, PhD – Laboratory of Method Development
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Ira J. Berkower, MD, PhD – Laboratory of Immunoregulation
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Division of Bacterial, Parasitic & Allergenic Products
Milan S. Blake, PhD
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Jay E. Slater, MD – Deputy Director
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Ronald L. Rabin, MD – Laboratory of Immunobiochemistry
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Willie F. Vann, PhD – Laboratory of Bacterial Polysaccharides
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Sheldon L. Morris, PhD – Laboratory of Mycobacterial Diseases & Cellular Immunology
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Drusilla L. Burns, PhD – Laboratory of Respiratory & Special Pathogens
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Dennis J. Kopecko, PhD – Laboratory of Enteric & Sexually Transmitted Diseases
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Vacant – Laboratory of Methods Development & Quality Control
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Division of Vaccines & Related Products Applications
Wellington Sun, MD
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Loris D. McVittie, PhD – Deputy Director
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Paul G. Richman, PhD – CMC Review Branch 1
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Rakesh Pandey, PhD – CMC Review Branch 2
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Elizabeth M. Sutkowski, PhD – CMC Review Branch 3
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Douglas R. Pratt, MD – Clinical Review Branch 1
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Lewis K. Schrager, MD – Clinical Review Branch 2
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Laraine S. Henchal – Review Management Support Branch
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OFFICE OF COMPLIANCE AND BIOLOGICS QUALITY
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Mary Anne Malarkey – DIRECTOR
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Leslie Kux, J.D. – Deputy Director
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Thomas J. Adams – Special Assistant to the Director
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Anita F. Richardson – Associate Director for Policy
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Jessica A. Tave, J.D. – Associate Director for Regulatory Policy
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Edward Patten – Associate Director for Manufacturing Science
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Jalena G. Specht, J.D. – Associate Director for Safety and Communication
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Sujay Pandey, J.D. – Associate Director for Bioinformatics
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Joseph P. Manik – Special Assistant for Imports & Product Availability
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Linda E. Silvers, DVM, MPH – Special Assistant for Manufacturing and Policy
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Division of Case Management
Robert A. Sausville
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Ele Ibarra-Pratt, RN, BSN, MPH – Advertising & Promotional Labeling Branch
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Diane S. Alexander – Biological Drug and Device Compliance Branch
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Stephany J. Wesley – Blood and Tissue Compliance Branch
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Division of Inspections & Surveillance
Gilliam B. Conley
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Patricia A. Holobaugh – Bioresearch Monitoring Branch
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Janet L. Ishimoto – Program Surveillance Branch
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Vacant – Program Inspection Branch
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Division of Manufacturing and Product Quality
John A. Eltermann, Jr. PharmD, MD
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Laurie P. Norwood – Deputy Director
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Joseph Quander, III – Product Release Branch
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Carolyn A. Renshaw – Manufacturing Review Branch I
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Chiang Syin, PhD – Manufacturing Review Branch II
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OFFICE OF CELLULAR, TISSUE AND GENE THERAPIES
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Celia M. Witten, MD, PhD – DIRECTOR
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Stephanie L. Simek, PhD – Deputy Director
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Patrick S. Riggins, PhD – Regulatory Management Staff
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Suzanne L. Epstein, PhD – Associate Director for Research
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Richard D. McFarland, MD – Associate Director for Policy
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Rachael Strong-Anatol, PhD – Associate Director for Policy (New Legislation)
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Theodore R. Stevens, MS – Associate Director for
Information Management
Information Management
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Division of Cellular & Gene Therapies
Raj K. Puri, MD, PhD
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Kimberly A. Benton, PhD – Deputy Director
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Keith M. Wonnacott, PhD – Cell Therapies Branch
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Daniel M. Takefman, PhD – Gene Therapies Branch
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Andrew Byrnes, PhD – Gene Transfer and Immunogenicity Branch
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Raj K. Puri, MD, PhD (Acting) – Tumor Vaccines and Biotechnology Branch
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Steven R. Bauer, PhD (Acting) – Cellular and Tissue Therapy Branch
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Division of Clinical Evaluation & Pharmacology / Toxicology
Celia M. Witten, MD, PhD
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Wilson W. Bryan, MD – Clinical Evaluation Branch
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Mercedes A. Serabian, MS, DABT – Pharmacology / Toxicology Branch
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Division of Human Tissues
Ellen F. Lazarus, MD
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Melissa Greenwald, MD – Human Tissue and Reproduction Branch
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CONTACT US:
Consumer Affairs Branch (CBER)
(800) 835-4709
(301) 827-1800
Email: ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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Center for Drug Evaluation and Research (FDA)
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States.
As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines. For example, fluoride toothpaste, antiperspirants, dandruff shampoos and sunscreens are all considered “drugs.”
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Key Officials
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June 22, 2010
OFFICE OF THE CENTER DIRECTOR (OCD)
DIRECTOR
Janet Woodcock, M.D. 301-796-5400 WO 51/Rm. 6133
Executive Assistant
Sharnell Ligon 301-796-5400 WO 51/Rm. 6131
Deputy Director for Regulatory Programs
Douglas C. Throckmorton, M.D. 301-796-5400 WO 51/Rm. 6132
Deputy Center Director for Clinical Science
Robert Temple, MD. 301-796-2270 WO 22/Rm. 4212
Program Support Specialist
Janice Shelton 301-796-5400 WO 51/Rm. 6128
Associate Director for Planning and Business Informatics
Theresa Mullin, Ph.D. 301-796-3422 WO 51/Rm. 6338
Office Automation Assistant
Kathleen Smith 301-796-3429 WO 51/Rm. 6337
Drug Safety Oversight Board
Steven Osborne, M.D. 301-796-3604 WO 51/Rm. 5158
Project Specialist
Georgiann Lenzl 301-796-3515 WO 51/Rm. 5159
Associate Director for International Programs
Justina A. Molzon, J.D. 301-796-5400 WO 51/Rm. 6118
Ombudsman
Virginia Behr 301-796-3436 WO 51/Rm. 6158
Controlled Substance Staff
Michael Klein, Ph.D. 301-796-5402 WO 51/Rm. 5142
Supervisory Senior Management Officer
Jamie Metz 301-796-3417 WO 51/Rm. 6112
OFFICE OF PHARMACEUTICAL SCIENCE (OPS)
Director
Helen Winkle 301-796-2400 WO 51/Rm. 4184
Technical Information Specialist
Vera Viehmann 301-796-1622 WO 51/Rm. 4183
Deputy Director (Acting)
Gary Buehler 301-796-2400 WO 51/Rm. 4192
Director, Program Activities Review Staff
Jon Clark 301-796-1518 WO 51/Rm. 4178
Director, Operations Staff
Christopher Cole, MPA 301-796-1521 WO 51/Rm. 4196
Director, Science and Research Staff
Nakissa Sadrieh, Ph.D. 301-796-1598 WO 51/Rm. 4172
Director, New Drug Microbiology Staff
David Hussong, Ph.D. 301-796-1228 WO 51/Rm. 4166
Scientific Coordinator
Russell Wesdyk, M.B.A. 301-796-1552 WO 51/Rm. 4183
OFFICE OF BIOTECHNOLOGY PRODUCTS (OBP)
Director
Steven Kozlowski, M.D. 301-796-2390 WO 21/Rm. 1510
Deputy Director
Vacant 301-796-2390 WO 21/Rm. 1506
Associate Director of Medical Affairs
Kenneth Hyams, M.D., M.P.H. 301-796-4797 WO 21/Rm. 1518
Associate Director for Operations 301-796-1773 WO 21/Rm. 1514
Marilyn Welschenbach, Ph.D.
Management Officer
James Selby, Jr. 301-796-1774 WO 21/Rm. 1516
Division of Monoclonal Antibodies (DMA)
Director
Kathleen Clouse, Ph.D. HFD-123 301-827-0850 NIH 29B RM. 4NN12
Deputy Director
Patrick Swann, Ph.D. HFD-123 301-827-0850 NIH 29B RM. 3NN10
Division of Therapeutic Proteins (DTP)
Director
Amy Rosenberg, M.D. HFD-122 301-827-1790 N29A/Rm. 2D16
Deputy Director
Barry Cherney, Ph.D. HFD-122 301-827-1790 N29A/Rm. 2D16
OFFICE OF TESTING AND RESEARCH (OTR)
Director
Vincent Vilker, Ph.D. 301-796-0200 WO 22/Rm. 2130
Deputy Director
Vacant
Associate Director for Research Policy
Joseph Hanig 301-796-0079 WO 22/Rm. 2134
Management Officer (Actg.) 301-796-1213 WO22/Rm. 3145
Derek Hicks
Management Specialist
Geoff Salyer 301-796-0202 WO 22/Rm. 2128
Laboratory of Clinical Pharmacology (LCP)
Director
Thomas Colatsky, Ph.D. (Acting) 301-796-0078 WO 64/Rm. 2078
Division of Applied Pharmacology Research (DAPR)
Director
Thomas Colatsky, Ph.D. 301-796-0078 WO 64/Rm. 2078
Deputy Director
Vacant 301-796-0079 WO 64/Rm. 2076
Division of Product Quality Research (DPQR)
Director
Mansoor Khan, Ph.D. 301-796-0016 WO 64/Rm. 1006
Deputy Director
Vacant
Division of Pharmaceutical Analysis (DPA)
Director
Lucinda F. Buhse, Ph.D. HFD-920 314-539-2134 1114 Market St.
Rm 1002
St. Louis, MO 63101
Deputy Director
Benjamin Westenberger HFD-920 314-539-3869 1114 Market St.
Rm. 1002
St. Louis, MO 63101
OFFICE OF GENERIC DRUGS (OGD)
Director
Gary J. Buehler, R. Ph. HFD-600 240-276-9310 MPN4/Rm. 3020
Technical Information Specialist
Patricia Downs HFD-600 240-276-9310 MPN4/Rm. 3010
Deputy Director
Robert West, R.Ph. HFD-601 240-276-9310 MPN 2/Rm. E283
Director for Science
Lawrence Yu, Ph.D. HFD-600 240-276-9310 MPN4 /Rm. 3014
Associate Director for Medical Affairs
Dena Hixon, M.D. HFD-600 240-276-9310 MPN2/Rm. 2210
Associate Director for Chemistry
Frank O. Holcombe, Jr., Ph.D. HFD-600 240-276-9310 MPN2/Rm. N131
Associate Director for Operations
and Communications
Rita Hassall, R.N. HFD-600 240-276-9310 MPN4/Rm. 3019
Management Officer
Patricia Littleton HFD-600 240-276-9322 MPN4/Rm. 3024
Division of Chemistry I (DCI)
Director (Acting)
Paul Schwartz, PhD. HFD-621 240-276-8500 MPN2/Rm. 206
Deputy Director
Vacant HFD-621 240-276-8500 MPN2/Rm. 206
Division of Chemistry II (DCII)
Director
Florence Fang, Ph.D. HFD-640 240-276-8505 MPN2/Rm. E270
Deputy Director
Richard Adams, Ph.D. HFD-640 240-276-8505 MPN2/Rm. E270
Division of Chemistry III (DCIII)
Director
Vilayat Sayeed, Ph.D. HFD-630 240-276-8444 MPN2/Rm. E133
Deputy Director
Devinder Gill HFD-630 240-276-8444 MPN2/Rm E134
Division of Bioequivalence (DB)
Director
Dale Conner, Pharm.D. HFD-650 240-276-8782 MPN1/Rm. 1341
Deputy Director
Barbara Davit, Ph.D. HFD-651 240-276-8782 MPN1/Rm. 1343
Division of Labeling and Program Support (DLPS)
Director
Peter Rickman HFD-610 240-276-8400 MPN2/Rm. N129
Deputy Director
Vacant
OFFICE OF NEW DRUG QUALITY ASSESSMENT (ONDQA)
Director
Moheb Nasr 301-796-1724 WO 21/Rm. 2630
Technical Information Specialist
Patricia O’Connor 301-796-1727 WO 21/Rm 2691
Deputy Director
Christine Moore, Ph.D. (Actg) 301-796-1422 WO 21/Rm 2626
Assistant Director for Regulatory Science and Policy
John Smith, Ph.D. 301-796-1757 WO 21/Rm 2619
Associate Director for Product Quality- Urgent Response
Norm Schmuff, Ph.D. 301-794-1454 WO 21/Rm 2526
Associate Director for Regulatory Affairs
Michael Folkendt 301-796-1670 WO 21/Rm 2668
Associate Director for Bio Pharmaceutics
Arzu Selen, Ph.D. 301-796-1603 WO 21/Rm 2618
Program Manager
David Morley 301-796-1719 WO 21/Rm 2672
Management Officer
Shanell Owens 301-796-1729 WO 21/Rm 2677
Division of Pre-Marketing Assessment I (DPA I)
Director
Terry Ocheltree, Ph.D. 301-796-2410 WO 21/Rm 2526
Branch Chief
Ramesh Sood, Ph.D. 301-796-1466 WO 21/Rm 2530
Branch Chief, Ph.D.
Prasad Peri, Ph.D. (Acting) 301-796-1730 WO 21/Rm 2558
Division of Pre-Marketing Assessment II (DPA II)
Director
Elaine Morefield, Ph.D. 301-796-1987 WO 22/Rm 1442
Branch Chief
Stephen Miller, Ph.D. (Acting) 301-796-1418 WO 22/Rm 1446
Branch Chief
Moo Jhong Rhee 301-796-1440 WO 22/Rm 1462
Division of Pre-Marketing Assessment III & Manufacturing Science (DPAMS)
Director
Richard Lostritto, Ph.D. 301-796-2430 WO 22/Rm 1626
Branch Chief
Richard Lostritto, Ph.D. (Acting) 301-796-2430 WO 22/Rm 1626
Branch Chief
Sarah Pop-Miksinski, Ph.D. 301-796-1436 WO 22/Rm 1624
Division of Post-Marketing Evaluation (DPE)
Director
Eric Duffy, Ph.D. 301-796-2440 WO 21/Rm 2614
Branch Chief
James Vidra, Ph.D. 301-796-1767 WO 21/Rm 2620
Branch Chief
Hasmukh Patel, Ph.D. 301-796-2440 WO 21/Rm 2616
OFFICE OF REGULATORY POLICY (ORP)
Director
Jane A. Axelrad, J.D. 301-796-5400 WO 51/Rm. 6216
Deputy Associate Director for Policy
Vacant
Special Assistant
Michael D. Jones 301-796-3602 WO 51/Rm. 6216
Management Officer
Michelle Bacon 301-796-3764 WO 51/Rm. 6114
Program Support Specialist
Paula Fidel-Aitken 301-796-3428 WO 51/Rm. 6143
Division of Regulatory Policy I (DRPI)
Director
Nancy Boocker, J.D. 301-796-3601 WO 51/Rm. 6244
Division of Regulatory Policy II (DRPII)
Director
Michael Bernstein, J.D. 301-796-3602 WO 51/Rm. 6240
Division of Regulatory Policy III (DRPIII)
Director
Nam Kim, J.D. 301-796-3472 WO 51/Rm. 6358
Division of Information Disclosure Policy (DIDP)
Director
Nancy Sager 301-796-3603 WO 51/Rm. 6264
OFFICE OF EXECUTIVE PROGRAMS (OEP)
Director
Deborah Henderson 301-796-1446 WO 51/Rm. 6148
Deputy Director
Jayne Ware 301-796-3433 WO 51/Rm. 6152
Director’s Secretary
Breana McLaren 301-796-5102 WO 51/Rm. 6145B
Executive Operations Staff
Christine Bechtel 301-796-3449 WO 51/Rm. 6186
Advisors and Consultants Staff
Jayne Peterson HFD-021 301-827-6762 FHSL/Rm. 1084
Management Officer
Melanie Whalen 301-796-4268 WO 51/Rm. 6106
OFFICE OF MANAGEMENT (OM)
Director
Mary Milline (Acting) 301-796-3300 WO 51//Rm. 5135
Secretary
Tiffany Bray 301-796-3300 WO 51//Rm. 5135
Deputy Director
Bob Linkous (Acting) 301-796-3300 WO 51//Rm. 5135
Management Officer
Rebecca E. Glidden HFD-060 301-796-4417 MM2/Rm. 305
Division of Management and Budget (DMB)
Director
Rixie Scott HFD-050 301-796-4405 MM2/Rm. 306
Planning and Resource Management Branch
Katie Green HFD-050 301-796-4404 MM2I/Rm. 307
Management Analysis Branch
Don Kim HFD-050 301-796-4407 MM2/Rm. 309
Division of Management Services (DMS)
Director
Mary Milline HFD-060 301-796-4428 MM2/Rm. 340
Deputy Director
Tania Tse HFD-060 301-796-4453 MM2/Rm. 342
Program Management Services Branch
Patricia Gathers HFD-065 301-796-4445 MM2/Rm. 333
Interface Management Branch (IMB)
Mark Meredith (Acting) HFD-067 301-796-4113 MM2/Rm. 347
OFFICE OF NEW DRUGS (OND)
Director
John Jenkins, M.D. 301-796-0700 WO 22/Rm. 6304
Executive Assistant
Victor Vail 301-796-3169 WO 22/Rm. 6305
Deputy Director
Sandra Kweder, M.D. 301-796-0700 WO 22/Rm. 6306
Supervisory Senior Management Officer
Eldridge Coles 301-796-0141 WO 22/Rm. 6418
Associate Director of Pharmacology and Toxicology
David Jacobson-Kram, Ph.D., D.A.B.T. 301-796-0175 WO 22/Rm. 6488
Associate Director for Regulatory Affairs
Kim Quaintance 301-796-0700 WO 22/Rm. 6300
Associate Director, Study Endpoints & Labeling Development
Laurie Burke, R.Ph., M.P.H 301-796-0900 WO 22/Rm. 6462
Associate Director, Pediatrics & Maternal Health Staff
Lisa Mathis, M.D. 301-796-2200 WO 22/Rm. 6414
Lead Medical Officer, Guidance/Policy Team
Sally Loewke, M.D. 301-796-0700 WO 22/Rm. 6312
OFFICE OF DRUG EVALUATION I (ODEI)
Director
Robert J. Temple, M.D. (Acting) 301-796-2270 WO 22/Rm. 4212
Assistant
Aprile Blount 301-796-2270 WO 22/Rm. 4217
Deputy Director
Dr. Ellis Unger 301-796-2270 WO 22/Rm. 4208
Associate Director for Regulatory Affairs
Colleen LoCicero 301-796-2270 WO 22/Rm. 4216
Management Officer
Tammy Sauter 301-796-2270 WO 22/Rm. 4206
Division of Cardiovascular Renal Products (DCRP)
Director
Norman Stockbridge, M.D., Ph.D. 301-796-2240 WO 22/Rm. 4168
Deputy Director
Stephen Grant, M.D. 301-796-2240 WO 22/Rm. 4170
Supervisory Project Manager
Edward Fromm 301-796-2240 WO 22/Rm. 4162
Division of Neurology Products (DNP)
Director
Russell G. Katz, M.D. 301-796-2250 WO 22/Rm. 4332
Deputy Director
Eric Bastings, M.D. 301-796-2250 WO 22/Rm. 4330
Supervisory Project Manager
Robbin Nighswander, R.Ph. 301-796-2250 WO 22/Rm. 4200
Jacqueline Ware, R.Ph. 301-769-2250 WO 22/Rm. 4346
Division of Psychiatry Products (DPP)
Director
Thomas Laughren, M.D. 301-796-2260 WO 22/Rm. 4114
Deputy Director
Mitchell Mathis, M.D. 301-796-2260 WO 22/Rm. 4112
Supervisory Project Managers
Steven Hardeman, R.Ph. 301-796-2260 WO 22/Rm. 4390
Paul David, R.Ph. 301-796-2260 WO 22/Rm. 4100
OFFICE OF DRUG EVALUATION II (ODEII)
Director
Curtis Rosebraugh, M. D. 301-796-2310 WO 22/Rm. 3214
Secretary
Velma Cunningham 301-796-2310 WO 22/Rm. 3221
Deputy Director
Vacant 301-796-2310 WO 22/Rm 3210
Associate Director for Regulatory Affairs
Leah Ripper 301-796-1282 WO 22/Rm. 3218
Management Officer
Thomas Cunningham 301-796-1196 WO 22/Rm. 3208
Division of Metabolism and Endocrinology Products (DMEP)
Director
Mary Parks, M.D. 301-796-2290 WO 22/Rm. 3362
Deputy Director
Eric Colman, M.D. 301-796-1190 WO 22/Rm. 3360
Supervisory Project Managers
Enid M. Galliers 301-796-1211 WO 22/Rm. 3356
Lina Aljuburi 301-796-1168 WO 22/Rm. 3366
Division of Pulmonary and Allergy Products (DPAP)
Director
Badrul Chowdhury, M.D. 301-796-2300 WO 22/Rm. 3316
Deputy Director
Lydia Gilbert-McClain, M.D. 301-796-2300 WO 22/Rm. 3310
Supervisory Project Manager
Sandra L. Barnes 301-796-1174 WO 22/Rm. 3306
Division of Analgesics, Anesthetics, and Rheumatology Products (DAARP)
Director
Bob A. Rappaport, M.D. 301-796-2280 WO 22/Rm. 3168
Deputy Director
Sharon Hertz, M.D. 301-796-2280 WO 22/Rm. 3170
Deputy Director
Rigoberto Roca, M.D. 301-796-2280 WO 22/Rm. 3136
Supervisory Project Managers
Parinda Jani 301-796-1232 WO 22/Rm. 3166
Sara Stradley 301-796-1298 WO 22/Rm. 3162
OFFICE OF DRUG EVALUATION III (ODEIII)
Director
Julie Beitz, M.D. 301-796-2100 WO 22/Rm. 5214
Program Support Specialist
Diane Thomas 301-796-0220 WO 22/Rm. 5221
Deputy Director
Vacant 301-796-2100 WO 22/Rm. 5210
Associate Director for Regulatory Affairs
Maria Walsh 301-796-2100 WO 22/Rm. 5218
Management Officer
Antoinette Mason 301-796-0954 WO 22/Rm. 5206
Division of Reproductive and Urologic Products (DRUP)
Director
Scott Monroe, M.D. 301-796-2130 WO 22/Rm. 5380
Deputy Director
George Benson, M.D. 301-796-2130 WO 22/Rm. 5346
Supervisory Project Managers
Margaret Kober 301-796-2130 WO 22/Rm. 5376
Jennifer Mercier 301-796-2130 WO 22/Rm. 5358
Division of Gastroenterology Products (DGP)
Director
Donna Griebel, M.D. 301-796-2120 WO 22/Rm. 5112
Deputy Director
Vacant 301-796-2120 WO 22/Rm. 5114
Supervisory Project Managers
Richard Wes Ishihara 301-796-2120 WO 22/Rm. 5118
Brian Strongin 301-796-2120 WO 22/Rm. 5116
Division of Dermatology and Dental Products (DDDP)
Director
Susan Walker, M.D. 301-796-2110 WO 22/Rm. 5168
Deputy Director
Stanka Kukich, M.D. 301-796-2110 WO 22/Rm. 5170
Supervisory Project Manager
Barbara Jean Gould 301-796-2110 WO 22/Rm. 5166
OFFICE OF ANTIMICROBIAL PRODUCTS (OAP)
Director
Edward Cox, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6212
Deputy Director
John J. Farley, M.D., M.P.H. 301-796-1300 WO 22/Rm. 6208
Associate Director for Regulatory Affairs
David Roeder 301-796-0799 WO 22/Rm. 6216
Management Officer
Dana Schuhly 301-796-0806 WO 22/Rm. 6242
Division of Anti-Infective and Ophthalmology Products (DAIOP)
Director
Wiley A. Chambers, M.D., (Acting) 301-796-0690 WO 22/Rm. 6336
Deputy Director
Wiley A. Chambers, M.D. 301-796-0690 WO 22/Rm. 6336
Deputy Director
Katherine Laessig, M.D. 301-796-0746 WO 22/Rm. 6380
Supervisory Project Managers
Frances LeSane 301-796-0747 WO 22/Rm. 6112
Maureen Dillon-Parker 301-796-0706 WO 22/Rm. 6134
Division of Anti-Viral Products (DAVP)
Director
Debra Birnkrant, M.D. 301-796-0682 WO 22/Rm. 6332
Deputy Director
Jeffrey Murray, M.D., MPH 301-796-0770 WO 22/Rm. 6360
Supervisory Project Managers
Victoria Tyson 301-796-0827 WO 22/Rm. 6330
Karen Winestock 301-796-0834 WO 22/Rm. 6322
Division of Special Pathogen and Transplant Products (DSPTP)
Director
Renata Albrecht, M.D. 301-796-0664 WO 22/Rm. 6168
Deputy Director (Acting)
Eileen Navarro-Almario, M.D. 301-796-0773 WO 22/Rm. 6126
Supervisory Project Manager
Diana Willard 301-796-0833 WO 22/Rm. 6114
Supervisory Project Manager
Judit Milstein 301-796-0763 WO 22/Rm. 6170
OFFICE OF NONPRESCRIPTION PRODUCTS (ONP)
Director
Charles Ganley, M.D. 301-796-0895 WO 22/Rm. 5304
Secretary
Norma Jiggetts 301-796-0924 WO 22/Rm. 5301
Deputy Director
Shaw T. Chen, M.D. 301-796-1054 WO 22/Rm. 5306
Associate Director for Regulatory Affairs 301-796-0869 WO 22/Rm. 5300
Leah A. Christl, Ph,D
Associate Director
Susan Johnson, Pharm.D., Ph.D. 301-796-0925 WO 22/Rm. 5312
Management Officer
Merla Rae Matheny 301-796-0955 WO 22/Rm. 5314
Division of Nonprescription Clinical Evaluation (DNCE)
Director
Andrea Leonard-Segal, M.D. 301-796-0940 WO 22/Rm. 5474
Deputy Director
Joel Schiffenbauer, M.D. 301-796-1288 WO 22/Rm. 5478
Program Specialist
Pamela Hampton 301-796-09504 WO 22/Rm. 5303
Division of Nonprescription Regulation Development (DNRD)
Director
M. Scott Furness, Ph.D. 301-796-0893 WO 22/Rm. 6474
Deputy Director 301-796-0914 WO 22/Rm. 5414
Matthew R. Holman, Ph.D.
Program Specialist (Acting)
Merla Rae Matheny 301-796-0955 WO 22/Rm. 5314
OFFICE OF ONCOLOGY DRUG PRODUCTS (OODP)
Director
Richard Pazdur, M.D. 301-796-2340 WO 22/Rm. 2212
Secretary
Bertha Mejia 301-796-2340 WO 22/Rm. 2221
Deputy Director
Vacant 301-796-2340 WO 22/Rm. 2208
Associate Director for Regulatory Affairs
Tamy Kim (Acting) 301-796-2340 WO 22/Rm. 2200
Associate Director for Regulatory Science
Anthony Murgo, M.D. 301-796-2340 WO 22/Rm. 2208
Management Officer
Krista Yazdani (Acting) 301-796-1029 WO 22/Rm. 2215
Division of Biologic Oncology Products (DBOP)
Director
Patricia Keegan, M.D. 301-796-2320 WO 22/Rm. 2320
Program Specialist
Courtney Eley 301-796-2320 WO 22/Rm. 2325
Deputy Director
Joseph Gootenberg, M.D. 301-796-2320 WO 22/Rm. 2312
Supervisory CSO
Karen Jones 301-796-2320 WO 22/Rm. 2306
Division of Drug Oncology Products (DDOP)
Director
Robert Justice, M.D. 301-796-2330 WO 22/Rm. 2112
Secretary
Jameka Roberts 301-796-2330 WO 22/Rm. 2125
Deputy Director
Ann Farrell, M.D. 301-796-2330 WO 22/Rm. 2114
Deputy Director (Actg)
Anthony Murgo, M.D. 301-796-2330 WO 22/Rm. 2208
Supervisory CSO
Frank Cross 301-796-2330 WO 22/Rm. 2110
Supervisory CSO
Alice Kacuba 301-796-2330 WO 22/Rm. 2104
Division of Medical Imaging and Hematology Products (DMIHP)
Director
Rafel (Dwaine) Rieves, M.D. 301-796-2050 WO 22/Rm. 2348
Secretary
Kimberly Miller 301-796-1046 WO 22/Rm. 2375
Deputy Director
Libero Marzella, M.D. (Acting) 301-796-2050 WO 22/Rm. 2346
Supervisory CSO
Kyong Kang 301-796-2050 WO 22/Rm. 2352
OFFICE OF SURVEILLANCE AND EPIDEMIOLOGY (OSE)
Director
Gerald Dal Pan, M.D., M.H.S. 301-796-2380 WO 22/Rm. 4304
Program Support Specialist
Barbara M McCary 301-796-2000 WO 22/Rm. 4303
Deputy Director
Henry Francis, M.D. 301-796-2380 WO 22/Rm. 4300
Associate Director for Regulatory Affairs
Kathleen Frost 301-796-2380 WO 22/Rm. 4312
Supervisory Senior Management Officer
Amy Garvin 301-796-3413 WO 22/Rm. 4326
Outreach
Staff Director
Melissa Moncavage, M.P.H. (Acting) 301-796-2380 WO 22/Rm. 4308
Review Management Staff (RMS)
Staff Director
Sammie Beam (Actg.) 301-796-2380 WO 22/Rm. 4480
Division of Pharmacovigilance I (DPV I)
Director
Mark Avigan, M.D. (Acting) 301-796-2350 WO 22/Rm. 3478
Deputy Director
Ann McMahon, M.D. 301-796-2350 WO 22/Rm. 3474
Division of Pharmacovigilance II (DPV II)
Director
Robert Boucher, M.D. 301-796-2350 WO 22/Rm. 3420
Deputy Director
Mary Willy 301-796-2350 WO 22/Rm. 3420
Division of Epidemiology (DEPI)
Director
Solomon Iyasu, M.D., M.P.H. 301-796-2370 WO 22/Rm. 2472
Deputy Director
Amarilys Vega, M.D. 301-796-2370 WO 22/Rm. 2474
Division of Risk Management (DRISK)
Director
Mary Willy, Pharm.D. 301-796-5400 WO 22/Rm. 2416
Deputy Director
Vacant
Division of Medication Errors Prevention and Analysis (DMEPA)
Director
Carol Holquist, R.Ph. 301-796-2360 WO 22/Rm. 4416
Deputy Director
Denise Toyer, Pharm.D., R.PH 301-796-0549 WO 22/Rm. 4414
OFFICE OF TRANSLATIONAL SCIENCES (OTS)
Director
ShaAvhree Buckman, M.D., Ph.D.,
F.A.A.P. 301-796-1721 WO 21/Rm. 4554
Program Support Specialist
Kiesha Houston 301-796-2600 WO21/Rm. 4526
Deputy Director
Susan McCune (Acting) 301-796-1709 WO 21/Rm. 4554
Supervisory Senior Management Officer
Raya S. McCree 301-796-1708 WO 21/Rm. 4512
Associate Director for Regulatory Affairs
Rubynell Jordan, BSN, MPA 301-796-3453 WO 22/Rm. 4528
Research Coordinator
CAPT Frances T. Gipson 301-796-0166 WO 21/Rm. 4542
Associate Director for Science
Jan Johannessen 301-796-2600 WO 21/Rm. 4546
OFFICE OF BIOSTATISTICS (OB)
Director
Robert O’Neill, Ph.D. 301-796-1700 WO 21/Rm. 3554
Program Support Specialist
Shereese Johnson (Acting) 301-796-1314 WO 21/Rm. 3547
Deputy Director
Edward Nevius, Ph.D. 301-796-1263 WO 21/Rm. 3550
Associate Director
Sue Jane Wang, Ph.D. 301-796-0831 WO 21/Rm. 3526
Associate Director for Statistical Science & Policy
Ram Tiwari 301-796-4084 WO 21/Rm. 3524
Management Officer
Lisa Gilmer 301-796-1768 WO 21/Rm. 4517
Division of Biometrics I (DBI)
Director
James Hung, Ph.D. 301-796-1092 WO 21/Rm. 4616
Deputy Director
Kooros Mahjoob, Ph.D. 301-796-1115 WO 21/Rm. 4614
Division of Biometrics II (DBII)
Director
Thomas Permutt, Ph.D. 301-796-1271 WO 21/Rm. 3614
Deputy Director
Jon Sahlroot 301-796-1286 WO 21Rm. 3612
Division of Biometrics III (DBIII)
Director
Stephen Wilson, Ph.D. 301-796-0579 WO 21/Rm. 3630
Division of Biometrics IV (DBIV)
Director
Mohammad Huque, Ph.D. 301-796-1800 WO 21/Rm. 3510
Deputy Director
Daphne Lin, Ph.D. 301-796-0751 WO 21Rm. 3508
Division of Biometrics V (DBV)
Director
Aloka G. Chakravarty, Ph.D. 301-796-1655 WO 21/Rm. 3514
Deputy Director
Rajeshwari Sridhara 301-796-1759 WO 21/Rm. 3512
Division of Biometrics VI (DBVI)
Director
Stella Machado, Ph.D. 301-796-0949 WO 21/Rm. 4630
Deputy Director
Yi Tsong 301-796-1013 WO 21/Rm. 4628
OFFICE OF CLINICAL PHARMACOLOGY (OCP)
Director
Lawrence J. Lesko, Ph.D. 301-796-1565 WO 51/Rm. 3178
Program Support Specialist
Karen Graves 301-796-5008 WO 51/Rm. 3177
Deputy Director
Shiew-Mei Huang, Ph.D. 301-796-1541 WO 51/Rm. 3188
Associate Director of Genomics
Issam Zineh, Pharm.D. 301-796-4756 WO 51/Rm. 3182
Pharmacometrics Staff
Jogarao Gobburu, Ph.D. 301-796-1589 WO 51/Rm. 3186
Management Officer
Malcom Dennis 301-796-4107 WO 21/Rm. 4508
Division of Clinical Pharmacology I (DCPI)
Director
Mehul Mehta, Ph.D. 301-796-1573 WO 51/Rm. 2178
Deputy Director
Ramana S. Uppoor 301-796-1619 WO 51/Rm. 2182
Division of Clinical Pharmacology II (DCPII)
Director
Chandra Sahajwalla 301-796-1599 WO 51/Rm. 4550
Deputy Director
Suresh Doddapaneni 301-796-1526 WO 51/Rm. 3136
Division of Clinical Pharmacology III (DCPIII)
Director
Dennis Bashaw, Ph.D. 301-796-1502 WO 51/Rm. 3134
Deputy Director
Hae Young Ahn 301-796-1494 WO 51/Rm. 3132
Division of Clinical Pharmacology IV (DCPIV)
Director
John A. Lazor, Pharm.D. 301-796-1559 WO 51/Rm. 2134
Deputy Director
Kellie Reynolds 301-796-1594 WO 51/Rm.2142
Division of Clinical Pharmacology V (DCPV)
Director
Atik Rahman, Ph.D. 301-796-1591 WO 51/Rm. 2188
Deputy Director
Brian Booth 301-796-1508 WO 51/Rm. 2186
OFFICE OF MEDICAL POLICY (OMP)
Director
Rachel E. Behrman, M.D. 301-796-2500 WO 51/Rm. 6338
Assistant
Jennifer Hymiller 301-796-2500 WO 51/Rm. 6337
Deputy Director
Kathleen Uhl 301-796-2500 WO 51/Rm. 6342
Associate Director for Regulatory Affairs
Janet Norden 301-796-2500 WO 51/Rm. 6324
Senior Management Officer
Tammy Russell 301-796-2500 WO 51/Rm. 6332
Division of Drug Marketing, Advertising, and Communication
Director
Thomas W. Abrams, RPh, MBA 301-796-1200 WO 51/Rm. 3264
Deputy Director
Kristin Davis 301-796-1200 WO 51/Rm. 3274
Office of Business Process Support (OBPS)
Office of Planning & Informatics (OPI)
Director
Theresa Mullin, Ph.D. 301-796-3422 WO 51/Rm. 1178
Deputy Director
Mary Ann Slack 301-796-0603 WO 51/Rm. 1188
Executive Assistant 301-796-4957 WO51/Rm. 1183
Supervisory Senior Management Officer
Maria Andrews 301-796-2273 WO 51/Rm. 1184
Office of Planning & Analysis (OPA)
Director (Acting)
Theresa Mullin, Ph.D. 301-796-3422 WO51/Rm. 1178
Management Officer
Kathleen Tchoulakian 301-796-0570 WO 51/Rm. 1195
Analysis Staff (AS)
Staff Director
Marta Wosinska, Ph.D. 301-796-3673 WO 51/Rm. 1186
Planning & Evaluation Staff (PES)
Staff Director
Donal Parks 301-796-3848 WO 51/Rm. 1182
Office of Business Informatics (OBI)
Director (Acting)
Gary Gensinger 301-796-0589 WO 22/Rm. 1112
Deputy Director
Gary Gensinger 301-796-0589 WO 22/Rm. 1112
Management Officer
Denise Townsend 301-796-2112 WO 22/Rm. 1135
Division of Project Development (DPD)
Division Director
Linda Sigg 301-796-0625 WO 22/Rm. 1114
Business Informatics Support Team
Binh Ta 301-796-4010 WO 22/Rm. 1111
Business Analysis Requirement Team
Amy Gomez 301-796-0322 WO 22/Rm. 1123
Division of Business Analysis & Reporting (DBAR)
Division Director
Yashika Rahaman 301-796-3843 WO 22/Rm. 1110
Reports Management Team
Michael Cu 301-796-0582 WO 22/Rm. 1165
Data Retrieval and Analysis Team
Nancy Maizel 301-796-0607 WO 22/Rm. 1106
Division of Regulatory Review Support (DRRS)
Division Director
Mark Gray 301-796-2081 WO 22/Rm. 1132
eSubmission Support Team
Virginia Ventura 301-796-1016 WO 22/Rm. 1161
eReview & eData Support Team
Zei-Pao Huang 301-796-0919 WO22/Rm. 1181
Division of Records Management (DRM)
Division Director
Franklin Stephenson 301-796-3872 WO 22/Rm. 1189
Records Management Team
Franklin Stephenson 301-796-3872 WO 22/Rm. 1189
Data Quality Management Team
Gail Stone 301-796-0629 WO 22/Rm. 1112
OFFICE OF COMMUNICATIONS (OCOMM)
Director
Julie Zawisza 301-796-3700 WO 51/Rm. 2342
Program Support Specialist
Brenda Adams 301-796-2015 WO 51/Rm. 2341
Deputy Director
Kimberly Rawlings (Acting) 301-796-3818 WO 51/Rm. 2350
Management Officer
Kelly Phelan 301-796-3176 WO 51/Rm. 2355
Division of Training and Development (DTD)
Director
Janice Newcomb 301-796-3178 WO 51/Rm. 2358
Deputy Director
Virginia Giroux 301-796-3179 WO 51/Rm. 2362
Division of Public Affairs (DPA)
Director
Ellen Frank 301-796-3121 WO 51/Rm. 2236
Project Specialist
Paul G Neff 301-796-3123 WO 51/Rm. 2238
Deputy Director
Anthony E. Sims 301-796-3126 WO 51/Rm. 2244
Division of Drug Information (DDI)
Director
Barry Poole 301-796-3145 WO 51/Rm. 2272
Deputy Director
Mary Kremzner 301-796-3144 WO 51/Rm. 2270
Division of Information Services (DIS)
Director
Sally Winthrop (Acting) 301-796-3135 WO 51/Rm. 2259
Deputy Director
Sally Winthrop 301-796-3135 WO 51/Rm 2259
OFFICE OF COMPLIANCE (OC)
Director
Deborah M. Autor, Esq. 301-796-3100 WO 51/Rm 5270
Program Support Specialst
Vacant
Project Specialist 301-796-3100 WO 51/Rm 5271
Marlene Sue Ling
Deputy Director
Ilisa Bernstein, Esq. (Acting) 301-796-4723 WO 51/
Associate Director
Douglas Stearn 301-796-3100 WO 51/Rm 5276
Associate Director of Scientific and Medical Affairs
Jason Woo, M.D. 301-796-3100 WO 51/Rm. 5278
Associate Director for Risk Analysis and Strategic Planning
H. Gregg Claycamp, M.S., Ph.D. 301-796-3130 WO 51/Rm. 4266
Associate Director of Operations
Terri Rumble 301-796-3363 WO 51/Rm. 5272
Senior Advisor
Kristi Hampton-Thurston 301-796-3238 WO 51/Rm. 5282
Special Assistant
Patricia Maroney-Benassi, Ph.D. 301-796-3357 WO 51/Rm. 5262
Associate Director of Business Operations
Mandee Rosenberg, Esq. 301-796-3313 WO 51/Rm. 5250
Senior Management Officer
Andrea Chen (Acting) 301-796-0139 WO 51/Rm. 5244
Regulatory Counsels
Meredith Francis, Esq. 301-796-3476 WO 51/Rm. 5258
Heather McDowell, Esq. 301-796-3296 WO 51/Rm. 5258
Harry Schwirck, Esq. 301-796-4271 WO 51/Rm. 5286
Project Management Officers
Rita Shapiro 301-796-3771 WO 51/Rm. 5281
George Smith 301-796-3205 WO 51/Rm. 5284
Chris Howard 301-796-3323 WO 51/Rm. 5260
Brenda Woods-Francis 301-796-3647 WO 51/Rm. 5281
Executive Communications Team
Kim Brown 301-796-4292 WO 51/Rm. 5208
Division of New Drugs and Labeling Compliance (DNDLC)
Director
Michael Levy, Esq. 301-796-3314 WO 51/Rm. 5188
Deputy Director
Kathleen Anderson, Pharm.D. 301-796-3309 WO 51/Rm. 5182
Associate Directors
Gail Bormel 301-796-3263 WO 51/Rm. 5186
Special Assistant
Daniel Nguyen 301-796-3303 WO 51/Rm. 5126
Project Management Officers (co-located)
Akilah Green 301-796-1219 WO 51/Rm. 5261
Alisea Crowley 301-796-1144 WO 51/Rm. 5196
Shelia Blackstock 301-796-4852 WO 51/Rm. 5263
OTC Drugs Team
Robert Heller 301-796-3353 WO 51/Rm. 5246
Internet and Health Fraud Team
Elizabeth Miller 301-796-3342 WO 51/Rm. 5176
Pharmacy Compounding Team
Samia Nasr, R.Ph., M.S. 301-796-3409 WO 51/Rm. 5174
New Drugs and Labeling Team
Judith McMeekin 301-796-3344 WO 51/Rm. 5237
Imports and Exports Team
Huascar Batista 301-796-3411 WO 51/Rm. 5374
Division of Manufacturing and Product Quality (DMPQ)
Director
Rick Friedman, M.S. 301-796-3268 WO 51/Rm. 4342
Deputy Director
Michael Smedley (Acting) 301-796-3273 WO 51/Rm. 4348
Associate Director for Drug Quality Assurance
Edwin Rivera-Martinez (Acting) 301-796-3274 WO 51/Rm. 4354
Associate Director for Regulatory Science
Vacant
Associate Director for Regulatory Affairs
Brian Belz (Acting) 301-796-4279 WO 51/Rm. 4233
Special Assistant
Paul Balcer 301-796-3235 WO 51/Rm. 4353
Ruby Tiwari, Pharm.D. (Acting) 301-796-4889 WO 51/Rm. 4135
Senior Advisor
Joy Sharp (Acting) 301-796-3647 WO 51/Rm. 5283
Regulatory Counsel
Emily Leongini 301-796-5380 WO 51/Rm. 4240
Project Management Officers (co-located)
Kennerly Chapman 301-796-3271 WO 51/Rm. 4346
Helen Saccone 301-796-4758 WO 51/Rm. 4228
Milinda Soukup 301-796-1444 WO 51/Rm 4228
Guidance and Policy Development Team
Michael Smedley 301-796-3273 WO 51/Rm. 4348
Brian Hasselbalch 301-796-3279 WO 51/Rm. 4364
Recalls and Shortages Branch
Grace McNally (Acting) 301-796-5723 WO 51/Rm. 4374
Recalls and Shortages Team 1
Israel Santiago 301-796-3285 WO 51/Rm. 4372
Recalls and Shortages Team 2
Karen Hirshfield, Pharm.D. (Acting) 301-796-1748 WO 51/Rm. 4320
Manufacturing Assessment and Preapproval Compliance Branch
Barry Rothman (Acting) 301-796-3281 WO 51/Rm. 4366
Edwin Rivera Martinez 301-796-3274 WO 51/Rm. 4354
New and Generic Drug Manufacturing Team 1
Tara Gooen 301-796-3257 WO 51/Rm. 4323
New and Generic Drug Manufacturing Team 2
Concepción Cruz 301-796-3254 WO 51/Rm. 4316
Biotech Manufacturing Team
Patricia Hughes, PhD. 301-796-3189 WO 51/Rm. 4328
Domestic Case Management Team 1
Teddi Lopez 301-796-3255 WO 51/Rm. 4368
Domestic Case Management Team 2
David Jaworski (Acting) 301-796-3192 WO 51/Rm. 4239
International Compliance Branch
Edwin Rivera-Martinez 301-796-3274 WO 51/Rm. 4354
Rosa Motta (Acting) 301-796-3282 WO 51/Rm. 4368
International Compliance Team 1
Carmelo Rosa 301-796-3667 WO 51/Rm. 4240
Hidee Molina (Acting) 301-796-3671 WO 51/Rm. 4223
International Compliance Team II
Karen Takahashi (Acting) 301-796-3193 WO 51/Rm. 4266
Division of Compliance Risk Management and Surveillance (DCRMS)
Director
H. Gregg Claycamp, M.S., Ph.D. 301-796-3130 WO 51/Rm. 4266
Deputy Director
Karen Kirchberg (Acting) 301-796-3233 WO 51/Rm. 4274
Project Management Officers (co-located)
Carl Huntley 301-796-1372 WO 51/Rm. 4270
Lyn Penniman 301-796-3685 WO 51/Rm. 5339
Surveillance and Data Analysis Branch
Jerry Yokoyama (Acting) 301-796-3642 WO 51/Rm. 4247
Risk Management and Strategic Problem Solving Team
Suzanne Barone, Ph.D. 301-796-3224 WO 51/Rm. 4258
Surveillance Programs Team
Elise Murphy 301-796-7565 WO 51/Rm. 4272
Data Analysis and Information Management Team
Lakshmi Cherukuri (Acting) 301-796-3243 WO 51/Rm. 4286
Drug Registration & Listing Team
Paul Loebach (Detail) 301-796-2173 WO 51/Rm. 4268
Senior Advisor
John Coburn 301-796-3237 WO 51/Rm. 4261
Joan Ginetis 301-796-3227 WO 51/Rm. 4262
Drug Quality Reporting System
Direct Line 301-796-3140
Division of Scientific Investigations (DSI)
Director
Leslie Ball, M.D. 301-796-3150 WO 51/Rm. 5342
Deputy Director
Joseph Salewski 301-796-3395 WO 51/Rm. 5348
Associate Director
CT Viswanathan, Ph.D. 301-796-3394 WO 51/Rm. 5346
Project Management Officers (co-located)
Chris Howard (Acting) 301-796-3323 WO 51/Rm. 5260
Human Subject Protection Team
Kevin Prohaska (Acting) 301-796-3707 WO 51/Rm. 5356
International Policy Team
Cynthia Kleppinger (Acting) 301-796-4286 WO 51/Rm. 5352
Good Clinical Practice Branch I
Constance Lewin, M.D. 301-796-3397 WO 51/Rm. 5354
Good Clinical Practice Team 1
Sherbet Samuels (Acting) 301-796-3385 WO 51/Rm. 5328
Good Clinical Practice Branch II
Tejashri Purohit-Sheth 301-796-3402 WO 51/Rm. 5358
Good Clinical Practice Team 2
Jean Mulinde (Acting) 301-796-0768 WO 51/Rm. 5318
Good Laboratory Practice and Bioequivalence Investigations Branch
Sam Haidar (Acting) 301-796-4777 WO 51/Rm. 5210
Bioequivalence Team
Martin Yau (Acting) 301-796-3381 WO 51/Rm. 5322
Good Laboratory Practice Team
Jackie O’Shaughnessy (Acting) 301-796-3389 WO 51/Rm. 5334
OFFICE OF COUNTER-TERRORISM AND EMERGENCY COODINATION (OCTEC)
Director
Rosemary Roberts, M.D. 301-796-2210 WO 51/Rm. 3342
Deputy Director
Brad Leissa, M.D. 301-796-2210 WO 51/Rm. 3348
Program Support Specialist
Darlene Johnson 301-796-1685 WO 51/Rm. 3341
Assoc. Dir. Emergency Risk Communication
Thomas J. Christle 301-796-2057 WO 51/Rm. 3358
Associate Director of Emergency Coordination
Susan McDermott, M.D. 301-796-1121 WO 51/Rm. 3362
Associate Director for Regulatory Affairs
Joanne Holmes, R.Ph. 301-796-1681 WO 51/Rm. 3352
Management Officer
Karen D. Smith 301-796-1756 WO 51/Rm. 3334
—————————————————————————————
——
Center for Devices and Radiological Health (FDA)
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. In addition, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
——
| Office of the Center Director | ||
| Center Director: | Jeffrey Shuren, M.D., J.D. | 301–796–5900 |
| Associate Director for Regulations and Policy | Nancy Stade, J.D. (Acting) | 301–796–5900 |
| Senior Associate Director | Lillian J. Gill, DPA | 301-796-5900 |
| Associate Director for Postmarket Operations | Jonathan Sackner-Bernstein, M.D. | 301-796-5420 |
| Deputy Director for Postmarket Operations | Diane Mitchell, M.D. | 301-796-5423 |
| Associate Director for Management and Executive Officer | Ruth E. McKee | 301-796-5900 |
| Associate Director for Clinical Research & Government Affairs | Vacant | 301-796-5900 |
| Senior Policy Analyst | Paul Fisher | 301-796-6176 |
| Ombudsman/Quality Assurance Manager | David Buckles, Ph.D., Acting | 301-796-5699 |
| Director, External Expertise and Partnerships | Nancy J. Pluhowski | 301-796-5696 |
| Program Management Officer | Joanna King | 301-796-5929 |
| Office of Management Operations | ||
| Director: | Frank Benedetti | 301-796-5449 |
| Deputy Director | Debbie Baclawski | 301-796-5757 |
| Program Management Officer | Joanna King | 301-796-5929 |
| Division of Ethics and Management Operations | Sandy Roderick-Molina | 301-796-5970 |
| Deputy Director | Shannon Gipson | 301-796-5968 |
| Occupational Health and Safety Officer | Tom Vegella | 301-796-2783 |
| Administrative Management Branch | Danyiel D’Antonio | 301-796-5967 |
| Integrity, Committee and Conference Management Branch | Kathleen Walker | 301-796-5964 |
| Freedom of Information Branch | Joy Lazaroff | 301-796-5946 |
| Division of Planning, Analysis, & Finance | Maria Boyreau | 301-796-5984 |
| Deputy Director | Marjorie Waskewich | 301-796-5989 |
| Planning Branch | Daniel Montgomery | 301-766-5987 |
| Analysis Branch | Bonnie Markovitz | 301-796-5972 |
| Financial Management Branch | Tracey Hill | 301-796-5976 |
| Office of Compliance | ||
| Director: | Timothy A. Ulatowski | 301-796-5500 |
| Deputy Director for Regulatory Affairs | Larry Spears | 301-796-5500 |
| Deputy Director for Medical Affairs | Kimber Richter | 301-796-5500 |
| Program Management Officer | Collin L. Figueroa | 301-796-5500 |
| Quality Management Staff | Frances Benedict | 301-796-5500 |
| Division of Risk Management Operations | Chester Reynolds (Acting) | 301-796-5530 |
| Deputy Director | Joanna Weitershausen | 301-796-5530 |
| Field Programs Branch | Allen Wynn | 301-796-5530 |
| Regulatory Policy and Systems Branch | David Racine (Acting) | 301-796-5530 |
| Recall Branch | Rita Hoffman | 301-796-5530 |
| Division of Bioresearch Monitoring | Michael Marcarelli | 301-796-5490 |
| Program Enforcement Branch A | Linda Godfrey | 301-796-5490 |
| Program Enforcement Branch B | Allen Lou (Acting) | 301-796-5490 |
| Special Investigations Branch | Anne Hawthorn (acting) | 301-796-5490 |
| Division of Enforcement A | Betty W. Collins | 301-796-5770 |
| Deputy Director | George Kroehling | 301-796-5770 |
| Dental, ENT and Ophthalmic Devices Branch | Ronald L. Swann | 301-796-5770 |
| OB/GYN, Gastro. & Urology Devices Branch | Paul Tilton | 301-796-5770 |
| General Hospital Devices Branch | Valerie Flournoy | 301-796-5770 |
| General Surgery Devices Branch | Thomas Knott | 301-796-5770 |
| Division of Enforcement B | Gladys Rodriguez | 301-796-5540 |
| Deputy Director | Stacie Bilek (Acting) | 301-796-5540 |
| Cardiac Rhythm and Electophysiology Devices Branch | Melissa Torres (Acting) | 301-796-5540 |
| Orthopedics and Physical Medicine & Anesthesiology Devices Branch | Matthew Krueger (Acting) | 301-796-5540 |
| Radiology, Anesthesiology & Neurology Devices Branch | Jennifer Medicus | 301-796-5540 |
| Vascular & Circulatory Support Devices Branch | Michelle Noonan-Smith (Acting) | 301-796-5540 |
| Office of Device Evaluation | ||
| Director: | Christy Foreman (Acting) | 301-796-5550 |
| Deputy Director for Clinical | Markham Luke, M.D., Ph.D. | 301-796-5550 |
| Deputy Director for Engineering and Science Review | Christy Foreman | 301-796-5550 |
| Deputy Director for Premarket Program Management | Barbara Zimmerman | 301-796-5550 |
| Advisory Panel Coordinator | Geretta Wood | 301-796-5550 |
| Program Management Office | Kathryn K. Appler | 301-796-5560 |
| Deputy Director | Sharyn (Lesa) A. Dowtin | 301-796-5560 |
| Program Operations Staff | Robert Gatling | 301-796-5640 |
| Premarket Approval Section | Robert Gatling (Acting) | 301-796-5640 |
| Investigational Device Exemption Section | Robert Gatling (Acting) | 301-796-5640 |
| Premarket Notification (510(k)) Section | Heather Rosecrans | 301-796-5640 |
| Division of Surgical, Orthopedic, and Restorative Devices | Mark Melkerson | 301-796-5650 |
| Deputy Director I | Barbara Buch, M.D. | 301-796-5650 |
| Deputy Director II | Peter Rumm, M.D. | 301-796-5650 |
| Plastic & Reconstructive Surgery Devices Branch | David Krause, Ph.D. | 301-796-6970 |
| General Surgery Devices Branch | Neil R. Ogden | 301-796-6930 |
| Orthopedic Joint Devices Branch | Jonette Foy, Ph.D. | 301-796-6910 |
| Orthopedic Spine Devices Branch | Ronald Jean, Ph.D. | 301-796-6920 |
| Restorative Devices Branch | Laurence Coyne, Ph.D. | 301-796-6900 |
| Division of Cardiovascular Devices | Bram D. Zuckerman, M.D. | 301-796-7000 |
| Deputy Director I | Donna Lochner | 301-796-7000 |
| Deputy Director II | William MacFarland | 301-796-7000 |
| Pacing, Defibrillator and Leads Branch | Mitchell Shein | 301-796-5630 |
| Cardiac Electrophysiology & Monitoring Devices Branch | Randall Brockman, M.D. (Acting) | 301-796-6316 |
| Interventional Cardiology Devices Branch | Ashley Boam | 301-796-5570 |
| Circulatory Support and Prosthetic Devices Branch | Matthew Hillebrenner | 301-796-6940 |
| Peripheral Vascular Devices Branch | Kenneth Cavanaugh, Ph.D. | 301-796-6950 |
| Division of Ophthalmic, Neurological, and ENT Devices | Malvina Eydelman, M.D. | 301-796-5620 |
| Scientific Deputy Director | Kesia Alexander, Ph.D. | 301-796-5620 |
| Clinical Deputy Director | Eric Mann, M.D., Ph.D. | 301-796-5620 |
| Associate Director | Deborah Falls | 301-796-5620 |
| Neurodiagnostic and Neurotherapeutic Devices Branch | Quynh Hoang | 301-796-6610 |
| Intraocular, Cornea and Neuromaterials Implants Branch | Tina Kiang, Ph.D. | 301-796-6860 |
| Ophthalmic Lasers, Neuromuscular Stimulators, and Diagnostics Branch | Bradley Cunningham (Acting) | 301-796-6620 |
| Ear, Nose, and Throat Devices Branch | Srinivas Nandkumar, Ph.D | 301-796-6890 |
| Division of Reproductive, Gastro-Renal, and Urological Devices | Janine Morris (Acting) | 301-796-6650 |
| Clinical Deputy Director | Herbert Lerner, M.D. | 301-796-6650 |
| Scientific Deputy Director | Nicole Wolanski (Acting) | 301-796-6650 |
| Obstetrics/Gynecology Devices Branch | Colin M. Pollard | 301-796-6650 |
| Urology and Lithotripsy Devices Branch | Michel Janda (Acting) | 301-796-6630 |
| Gastroenterology and Renal Devices Branch | Carolyn Neuland, Ph.D. | 301-796-5590 |
| Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices | Anthony Watson | 301-796-5580 |
| Deputy Director | M. Susan Runner, D.D.S. (Acting) | 301-796-5580 |
| Associate Director for Operations | Kwame Ulmer (Acting) | 301-796-5580 |
| Anesthesiology and Respiratory Devices Branch | Lester Schultheis,M.D. | 301-796-5580 |
| General Hospital Devices Branch | Charles Zimliki, Ph.D. (Acting) | 301-796-5580 |
| Infection Control Devices Branch | Geetha Javan, Ph.D. (Acting) | 301-796-5580 |
| Dental Devices Branch | M. Susan Runner, D.D.S. | 301-796-5580 |
| Office of In Vitro Diagnostic Device Evaluation and Safety | ||
| Director: | Alberto Gutierrez, Ph.D. | 301-796-5453 |
| Deputy Director, New Product Evaluation | Donald St. Pierre | 301-796-5454 |
| Deputy Director, Patient Safety and Product Quality | James L. Woods | 301-796-6225 |
| Associate Director for Policy and Operations | Mary S. Pastel, Sc.D. | 301-796-6887 |
| Chief Medical Officer | Robert L. Becker, Jr., M.D. | 301-796-5450 |
| Director, Personalized Medicine Staff | Elizabeth A. Mansfield, Ph.D. | 301-796-4664 |
| Associate Director for Clinical Studies | Marina V. Kondratovich, Ph.D. | 301-796-6036 |
| Associate Director for Science and Technology | Zivana Tezak-Fragale, Ph.D. | 301-796-6206 |
| Associate Director for Surveillance and Outreach Programs | Jean M. Cooper, D.V.M. | 301-796-5672 |
| Scientific Policy Advisor | Vacant | |
| Program Management Officer | David R. Warren | 301-796-6223 |
| Division of Chemistry and Toxicology Devices | Courtney C. Harper, Ph.D. | 301-796-5458 |
| Associate Director for Chemistry | Carol C. Benson | 301-796-5459 |
| Associate Director for Toxicology | Zhihao (Peter) Qiu, Ph.D. | 301-796-6655 |
| Division of Immunology and Hematology Devices | Maria M. Chan, Ph.D. | 301-796-5482 |
| Associate Director for Immunology | Reena Philip, Ph.D. | 301-796-6179 |
| Associate Director for Hematology | Leonthena Carrington | 301-796-6164 |
| Division of Microbiology Devices | Sally A. Hojvat, Ph.D. | 301-796-5455 |
| Associate Director for Bacteriology | Freddie M. Poole | 301-796-5457 |
| Associate Director for Virology | Uwe Scherf, Ph.D. | 301-796-5456 |
| Division of Radiological Devices | Donald St. Pierre (acting) | 301-796-5454 |
| Deputy Director | Vacant | |
| Office of Surveillance and Biometrics | ||
| Director: | Susan N. Gardner, Ph.D. | 301-796-5996 |
| Deputy Director | Vacant | 301-796-6005 |
| Deputy Director | Thomas P. Gross, M.D. | 301-796-5997 |
| Issues Management Staff | Vacant | |
| Program Management Staff | Donna Schwartz | 301-796-6004 |
| Division of Patient Safety Partnerships | Marilyn Flack | 301-796-6118 |
| Division of Epidemiology | Danica Marinac-Dabic, Ph.D., M.D. | 301-796-6689 |
| Epidemiology Evaluation and Research I | Ellen Pinnow | 301-796-6066 |
| Epidemiology Evaluation and Research II | Nilsa Loyo-Berrios | 301-796-6065 |
| Division of Postmarket Surveillance | Dave Buckles | 301-796-6052 |
| Deputy Director | Steven Chasin, Ph.D. | 301-796-6053 |
| Product Evaluation Branch I | Greg O’Connell | 301-796-6075 |
| Product Evaluation Branch II | Doug Wood | 301-796-6085 |
| Information Analysis Branch | Julie (Brandi) Stuart | 301-796-6573 |
| Reporting Systems Monitoring Branch | Sharon Kapsch | 301-796-6104 |
| Division of Biostatistics | Greg Campbell, Ph.D. | 301-796-5750 |
| Deputy Director | Gerry Gray | 301-796-6012 |
| Deputy Director | Lilly Yue | 301-796-6033 |
| Cardiovascular and Ophthalmic Devices Branch | Vacant | 301-796-6033 |
| Diagnostic Devices Branch | Lakshmi Vishnuvajjala | 301-796-6042 |
| General Surgical Devices Branch | Telba Irony | 301-796-6044 |
| Office of Science and Engineering Laboratories | ||
| Director: | Steven Pollack, Ph.D. | 301-796-2530 |
| Deputy Director for Program Policy and Evaluation | Subhas Malghan, Ph.D. | 301-796-2548 |
| Deputy Director for Science Evaluation and Coordination | Joel Myklebust, P.E., Ph.D. | 301-796-2491 |
| Associate Office Director for Enforcement Activities | Thomas Lee | 301-796-2554 |
| Associate Office Director for Regulatory Support | Joyce Whang, Ph.D. | 301-796-6516 |
| Associate Office Director for Laboratories | Charles Warr | 301-796-2556 |
| Management Support Staff | Angie Clingerman | 301-796-2569 |
| Standards Management Staff | Carol Herman | 301-796-6576 |
| Deputy Director, Standards Management Staff | LCDR Scott Colburn | 301-796-6287 |
| Division of Biology | Marilyn M. Lightfoote, M.D. | 301-796-0235 |
| Deputy Director | Vacant | |
| Deputy Director | Vacant | |
| Division of Physics | CAPT Victor Krauthamer, Ph.D. | 301-796-2474 |
| Deputy Director | Brian Beard, Ph.D. | 301-796-2469 |
| Deputy Director | Isaac Chang, Ph.D. | 301-796-2789 |
| Division of Solid and Fluid Mechanics | Laurence W. Grossman, Ph.D. | 301-796-2502 |
| Deputy Director | Jon Casamento | 301-796-2499 |
| Division of Chemistry and Materials Science | Dinesh Patwardhan, Ph.D. | 301-796-2622 |
| Deputy Director | Vacant | |
| Division of Imaging and Applied Mathematics | Kyle Myers, Ph.D. | 301-796-2533 |
| Deputy Director | Nicolas Petrick, Ph.D. | 301-796-2563 |
| Division of Electrical and Software Engineering | Alford Taylor, Jr. | 301-796-2583 |
| Deputy Director | Brian Fitzgerald | 301-796-2579 |
| Office of Communication, Education, and Radiation Programs | ||
| Director: | Lynne L. Rice | 301-796-5660 |
| Deputy Director for Technical and Radiological Initiatives | John L. McCrohan | 301-796-5719 |
| Deputy Director for Communication and Education | Heather D. Howell | 301-796-5718 |
| Associate Director for Outreach and Review | Mark H. Barnett | 240-276-3970 |
| Assistant Director for Program Operations | Clifford D. Evans | 301-796-6644 |
| Special Assistant to the Director | Sharon M. Davis | 301-796-5717 |
| Staff College Director | Jacqueline Woodard | 301-796-5670 |
| Staff College Deputy Director | Laura Stewart | 301-796-5673 |
| Regulations Staff Director | Nancy Pirt | 301-796-6248 |
| Division of Health Communication | Jay A. Rachlin | 301-796-5722 |
| Deputy Director | Laurel S. Mendelson | 301-796-5764 |
| Associate Director | Alvin W. Thomas | 301-796-5758 |
| Risk Communication Branch | Kristine B. Mejia | 301-796-5843 |
| Web Communication Branch | Edie Seligson (Acting) | 301-796-5768 |
| Division of Small Manufacturers, International and Consumer Assistance | John F. Stigi | 301-796-5848 |
| Deputy Director | William Sutton | 301-796-5849 |
| Technical Assistance Branch | Joseph V. Tartal | 301-796-5853 |
| Regulatory Assistance Branch | Yung Pak | 301-796-5856 |
| International Relations and External Affairs Staff | Carole C. Carey | 301-796-5708 |
| Division of Communication Media | Chad Heupel | 240-276-0922 |
| Television Design and Development Branch | Vacant | |
| Division of Mammography Quality and Radiation Programs | Helen J. Barr, M.D. | 301-796-5713 |
| Deputy Director | Thomas R. Ohlhaber | 301-796-5712 |
| Associate Director for Policy and Clinical Affairs | Charles A. Finder, M.D. | 301-796-5715 |
| Associate Director for Administration | Kathleen M. Sheridan | 301-796-5714 |
| Accreditation and Certification Branch | Kathleen A. Franke | 301-796-5710 |
| Radiation Programs Branch | Petro Shandruk | 301-796-5889 |
| Information Management Branch | Timothy J. Haran | 301-796-6625 |
| Inspection and Compliance Branch | Preetham Sudhaker | 301-796-5911 |
| Diagnostic Devices Branch | Sean M. Boyd | 301-796-5895 |
| Electronic Products Branch | Robert Doyle | 301-796-5863 |
—————————————————————————————
Center for Food Safety and Applied Nutrition (FDA)
The Center for Food Safety and Applied Nutrition, known as CFSAN, is one of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of the Food and Drug Administration (FDA). FDA is a scientific regulatory agency responsible for the safety of the nation’s domestically produced and imported foods, cosmetics, drugs, biologics, medical devices, and radiological products.
The Center has over 800 employees, who range from secretaries and other support staff to highly specialized professionals–such as chemists, microbiologists, toxicologists, food technologists, pathologists, molecular biologists, pharmacologists, nutritionists, epidemiologists, mathematicians, sanitarians, physicians and veterinarians.
The Center provides services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics. Most Center staff members work in the Center’s headquarters in College Park, Maryland. The Center also operates research facilities in Laurel, Maryland and in Dauphin Island, Alabama.
——
Main tele: 301-436-2357
Fax: 301-436-2647
Address: CPK-1 Room 4C-003
5100 Paint Bldg Branch
College Park, MD 20740
Fax: 301-436-2647
Address: CPK-1 Room 4C-003
5100 Paint Bldg Branch
College Park, MD 20740
——
Office of Management Systems
—
ASSOCIATE DIRECTOR FOR MANAGEMENT
Thomas D. Williams, M.B.A.
Thomas D. Williams, M.B.A.
DEPUTY DIRECTOR
Charles Sabatos
Charles Sabatos
SAFETY MANAGEMENT STAFF
Jim Zelinsky
Jim Zelinsky
(DHB)
——
DEPUTY DIRECTOR FOR OPERATIONS
Donald W. Kraemer (Acting)
Donald W. Kraemer (Acting)
INTERNATIONAL AFFAIRS STAFF
Camille E. Brewer, M.S., R.D.
(DHA)
Camille E. Brewer, M.S., R.D.
(DHA)
OFFICE OF FOOD DEFENSE, COMMUNICATION AND EMERGENCY RESPONSE
DIRECTOR
Faye Feldstein
(DHC)
DIRECTOR
Faye Feldstein
(DHC)
OFFICE OF FOOD SAFETY
DIRECTOR
Nega Beru, Ph.D.
(DHD)
DIRECTOR
Nega Beru, Ph.D.
(DHD)
OFFICE OF COSMETICS AND COLORS
DIRECTOR
Linda M. Katz, M.D., M.P.H.
(DHE)
DIRECTOR
Linda M. Katz, M.D., M.P.H.
(DHE)
OFFICE OF REGULATORY SCIENCE
DIRECTOR
Steven M. Musser, Ph.D.
(DHF)
DIRECTOR
Steven M. Musser, Ph.D.
(DHF)
OFFICE OF FOOD ADDITIVE SAFETY
DIRECTOR
Mitchell A. Cheeseman, Ph.D. (Acting)
(DHG)
DIRECTOR
Mitchell A. Cheeseman, Ph.D. (Acting)
(DHG)
——
Office of Food Defense, Communication and Emergency Response
—
DIRECTOR
Faye Feldstein
Faye Feldstein
DEPUTY DIRECTOR
Ted Elkin
(DHC)
Ted Elkin
(DHC)
——
Office of Regulatory Science
—
DIRECTOR
Steven M. Musser, Ph.D.
Steven M. Musser, Ph.D.
DEPUTY DIRECTOR
Vincent K. Bunning, Ph.D.
(DHF)
Vincent K. Bunning, Ph.D.
(DHF)
——
Office of Food Additive Safety
—
DIRECTOR
Mitchell A. Cheeseman, Ph.D. (Acting)
Mitchell A. Cheeseman, Ph.D. (Acting)
DEPUTY DIRECTOR
Paulette M. Gaynor (Acting)
Paulette M. Gaynor (Acting)
SENIOR SCIENCE POLICY STAFF
Dennis Keefe, Ph.D. (Acting)
(DHG)
Dennis Keefe, Ph.D. (Acting)
(DHG)
——
Office of the Center Director for Regulatory Affairs
—
DEPUTY DIRECTOR FOR REGULATORY AFFAIRS
Roberta F. Wagner (Acting)
(DHA)
Roberta F. Wagner (Acting)
(DHA)
OFFICE OF COMPLIANCE
DIRECTOR
Jennifer Thomas (Acting)
(DHH)
DIRECTOR
Jennifer Thomas (Acting)
(DHH)
OFFICE OF APPLIED RESEARCH AND SAFETY ASSESSMENT
DIRECTOR
Marleen Wekell, Ph.D.
(DHI)
DIRECTOR
Marleen Wekell, Ph.D.
(DHI)
OFFICE OF REGULATIONS POLICY AND SOCIAL SCIENCES
DIRECTOR
Susan M. Bernard, J.D., Dr.Ph., M.P.H. (Acting)
(DHJ)
DIRECTOR
Susan M. Bernard, J.D., Dr.Ph., M.P.H. (Acting)
(DHJ)
OFFICE OF NUTRITION, LABELING AND DIETARY SUPPLEMENTS
DIRECTOR
Barbara O. Schneeman, Ph.D.
(DHK)
DIRECTOR
Barbara O. Schneeman, Ph.D.
(DHK)
——
Office of Compliance
—
DIRECTOR
Jennifer Thomas (Acting)
Jennifer Thomas (Acting)
DEPUTY DIRECTOR
Vacant
(DHH)
Vacant
(DHH)
——
Applied Research and Safety Assessment
—
DIRECTOR
Marleen Wekell, Ph.D.
Marleen Wekell, Ph.D.
DEPUTY DIRECTOR
Marianne Miliotis, Ph.D.
Marianne Miliotis, Ph.D.
MUIRKIRK TECHNICAL OPERATIONS STAFF
Marianne Miliotis, Ph.D. (Acting)
(DHI)
Marianne Miliotis, Ph.D. (Acting)
(DHI)
——
Office of Regulations, Policy and Social Sciences
—
DIRECTOR
Susan M. Bernard, J.D., Dr.Ph, M.P.H. (Acting)
Susan M. Bernard, J.D., Dr.Ph, M.P.H. (Acting)
DEPUTY DIRECTOR
Vacant
(DHJ)
Vacant
(DHJ)
REGULATIONS AND SPECIAL GOVERNMENT EMPLOYEES MANAGEMENT STAFF
Susan M. Bernard, J.D., Dr.Ph, M.P.H.
(DHJ1)
Susan M. Bernard, J.D., Dr.Ph, M.P.H.
(DHJ1)
——
Office of Nutrition, Labeling and Dietary Supplements
—
DIRECTOR
Barbara O. Schneeman, Ph.D.
Barbara O. Schneeman, Ph.D.
DEPUTY DIRECTOR
Mary Poos, Ph.D.
(DHK)
Mary Poos, Ph.D.
(DHK)
FOOD LABELING AND STANDARD STAFF
Felcia B. Billingslea
(DHK1)
Felcia B. Billingslea
(DHK1)
NUTRITION PROGRAMS STAFF
Kathleen Ellwood, Ph.D.
(DHK2)
Kathleen Ellwood, Ph.D.
(DHK2)
INFANT FORMULA AND MEDICAL FOODS STAFF
Benson Silverman, M.D.
(DHK3)
Benson Silverman, M.D.
(DHK3)
*
Contact Us
Outreach and Information Center (HFS-009)
1-888-SAFEFOOD
1-888-723-3366
Consumers:
consumer@fda.gov
consumer@fda.gov
Industry:
industry@fda.gov
industry@fda.gov
Center for Food Safety and Applied Nutrition
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740
