Center for Drug Evaluation and
Research
Reference Guide
The Reference Guide lists CDER's main offices and phone numbers.
For specific information about drugs or drug products please contact
the following Division:
Food and Drug Administration
Center for Drug Evaluation and Research
Office of Training and Communication
Division of Drug Information
10903 New Hampshire Ave.
Silver Spring, MD 20903
Telephone number: (301) 827-4573 or 1-888-INFOFDA (463-6332).
E-mail address: druginfo@fda.hhs.gov |
Advertising, Rx Drugs (301) 796-1200
Advisory Committees (800) 741-8138
AIDS Clinical Trials Information (800) 422-6237
American Cancer Society (800) 227-2345
Application Integrity Policy (301) 594-0098
Biologics (CBER) (301) 827-2000
Breast Cancer Research (800) 344-8564
Breast Implant Consumer Inquiries (CDRH) (301) 594-0485
CDER Executive Secretary (301) 594-6779
CDER Therapeutic Biologics (301) 796-2390
Compliance (CBER) (301) 827-6190
Compliance (CDER) (301) 594-0054
Congressional Affairs (FDA/Office of
Legislative Affairs) (301) 443-3793
Consumer Product Safety Commission (800) 638-2772
Criminal Investigations (301) 294-4030
Division of Communications Management (CDER) (301) 827-1651
Drug Enforcement Administration (DEA) (800) 882-9539
Drug Information (301) 827-4570
Drug Shortages (301) 594-2456
Electronic Signatures (301) 827-8907
Electronic Submissions (CDER) Kenneth Edmunds (301) 594-5411
Environmental Officer (CDER) (301) 594-5629
Environmental Protection Agency (EPA) (800) 962-6215
ERIC (Employee Research & Information Center) (301) 827-ERIC
FDA Directory/Locator Information (301) 443-1544
Food (CFSAN) (888) 723-3366
Freedom of Information (301) 827-4565
Good Manufacturing Practices (GMP's) (301) 827-8907
Health Resources and Services Administration (301) 443-6593
IND/NDA General Information/Forms (301) 827-4573
Industry Questions (General) (301) 827-4573
Meat and Poultry Hotline (USDA) (800) 535-4555
MedWatch (800) FDA-1088
National Cancer Institute (NCI) (301) 496-5583
Information (800) 4-CANCER
National Clearinghouse for Drug Abuse (800) 729-6686
National Institute on Drug Abuse (NIDA) (301) 443-6480
NIH Directory Information (301) 496-2535
Office of Women's Health (301) 827-0350
Orphan Drugs (301) 827-3670
Patent and Trademark Office (703) 305-8341
Postmarketing Surveillance
(CDER) (Drug Quality/Data Processing) (301) 770-9299
(Compliance) (301) 827-8928
Press Office (FDA)(Print only) (301) 827-6242
Press Office (Foods only) (301) 436-2291
Press Office (FDA)Broadcast only) (301) 827-3434
Press Office (HHS) (202) 690-6343
Public Health Service (PHS) Employee Locator (301) 443-2414
Substance Abuse and Mental Health Services (800) 729-6686
Administration
Veterinary Medicine (CVM) (301) 827-7975
Videoteleconferencing/Speaker Tracking (CDER) (301) 827-1243
Back to Top
Office of the Commissioner
Andrew von Eschenbach, Commissioner (301) 827-2410
Office of the Chief Counsel
Sheldon T. Bradshaw, Chief Counsel (301) 827-1137
Office of Equal Opportunity (301) 827-4830
Director, Rosamelia T. Lecea
Office of the Administrative Law Judge (301) 827-7120
Daniel J. Davidson
Office of Associate Commissioner (301) 827-3330
for External Relations, Sheila Walcoff
Office of Policy, Planning, and Legislation (301) 827-3370
Randall Lutter, Senior Associate Commissioner
Office of Management and Systems (301) 255-6762
Kathleen D. Heuer, Associate Commissioner
Office of Science Coordination and Communication (301) 827-3340
Norris Alderson, Associate Commissioner
Office of Regulatory Affairs (301) 827-3101
Margaret Glavin, Associate Commissioner
Center for Biologics Evaluation and Research (301) 827-0372
Jesse Goodman, M.D.,MPH, Director
Center for Food Safety and Applied Nutrition (301) 436-1600
Robert E. Brackett, Ph.D, Director
Center for Drug Evaluation and Research (301) 594-5400
Janet Woodcock, MD, Acting Director
Center for Veterinary Medicine (301) 827-2950
Stephen F. Sundlof, D.V.M., Ph.D., Director
Center for Devices and Radiological Health (301) 827-7975
David W. Feigal, Jr., M.D., Ph.D., Director
Office of Executive Secretariat (301) 827-4450
LaJuana Caldwell, Director
National Center for Toxicological Research (870) 543-7517
William Slikker, Jr., Ph.D, Acting Director
Center for Drug Evaluation and Research
For additional information with complete structural layout of the Center for Drugs
Evaluation and Research refer to the organizational chart (see Table of Contents).
Office of the Center Director
Acting Center Director
Janet Woodcock,MD HFD-001 301-594-5400 RKWLII/Rm. 7100
Secretary
Dannette Alpern HFD-001 301-594-5400 RKWLII/Rm. 7100
Deputy Director
Douglas Throckmorton,MD HFD-001 301-594-5400 RKWLII/Rm. 7100
Secretary
Marjorie Lidard HFD-001 301-594-5400 RKWLII/Rm. 7100
Associate Director for Safety Policy and Communication
Paul Seligman, MD., M.P.H. HFD-001 301-443-5620 RKWLII/Rm. 5100
Program Support Specialist (detail)
Gala Abraham HFD-001 301-443-5570 RKWLII/Rm. 5100
Office of Drug Safety Oversight Board
vacant HFD-001 301-59-5400 RKWLII/Rm 7100
Associate Director for Medical Informatics
Randy Levin, M.D.,Director HFD-001 301-827-7784 PKLN/Rm. 9HH74
Ombudsman
Warren Rumble HFD-001 301 443-5581 RKWLII/Rm. 7236
Office Regulatory Policy
Associate Director for Policy
Jane A. Axelrad HFD-005 301-594-5400 RKWLII/Rm. 7106
Special Assistants
Nancy Derr HFD-005 301-594-5400 RKWLII/Rm. 7109
Michael D. Jones HFD-005 301-594-2041 RKWLII/Rm. 1118
Division of Regulatory Policy I
Director
Nancy Boocker, J.D. HFD-007 301-594-2041 RKWLII/Rm. 1108
Division of Regulatory Policy II
Director
Michael Bernstein HFD-007 301-594-2041 RKWLII/Rm. 1120
Division of Information Disclosure Policy
Director
Nancy Sager HFD-013 240-453-6666 MPNVI/Rm. 2128
OFFICE OF EXECUTIVE PROGRAMS
Director
Deborah J. Henderson HFD-006 301-594-5400 RKWLII/Rm.7104
Deputy Director
Jayne Ware HFD-006 301-594-5400 RKWLII/Rm.7108
Executive Operations Staff
Christine Bechtel HFD-006 301-443-5375 RKWLII/Rm.7224
Team Leader Program Management Team
Jamie Metz HFD-006 301-443-5362 RKWLII/Rm.7218
Quality Management Staff
Lana Pauls HFD-006 301-443-5369 RKWLII/Rm.1036
Advisor & Consultants Staff
Igor Cerny, Pharm.D. HFD-021 301-827-7001 RKWLII/Rm.1081
International Programs
Justina Moltzon HFD-001 301-443-5287 RKWLII/Rm.7107
Ombudsman
Warren Rumble HFD-001 301-443-5581 RKWLII/Rm 7326
Office Of Surveillance and Epidemiology (formerly Office of Drug Safety)
Director
Gerald DalPan,M.D. HFD-4316 301-796-2380
Acting Deputy Director for Science
Ellis Unger, M.D. HFD-4116 301-827-2380
Deputy Director of Operations
Ralph Lillie HFD-4116 301-827-2380
Associate Director for Regulatory Affairs
Kathleen Frost HFD-4316 301-827-2380
Program Support Specialist
Barbara McCary HFD-4316 301-827-2380
Office Automations Clerk
Chrishona Payne HFD-4316 301-827-2380
Division of Drug Risk Evaluation
Director
Mark Avigan, M.D. HFD-3411 301-796-2350
Deputy Director
Rosemary Johann-Liang,M.D. HFD-3411 301-796-2350
Associate Division Director
Min Chu Chen HFD-3411 301-796-2350
Program Support Assistant
Jo'el Plummer HFD-3411 301-796-2350
Program Support Assistant
Marta De Arce Buhay HFD-3411 301-796-2350
Project Managers:
Sandy Birdsong HFD-3411 301-796-0090
Sammie Beam HFD-3411 301-796-0080
Samuel Chan HFD-3411 301-796-2283
Jenna Lyndly HFD-3411 301-796-2224
Angela Robinson HFD-3411 301-796-2282
Division of Surveillance, Research and Communication Support
Director
Solomon Iyasu HFD-4447 301-796-2370
Deputy Director
Toni Piazza-Hepp, M.D.. HFD-4447 301-796-2370
Program Support Assistant
Daniel Gittleson HFD-4447 301-796-2370
Project Manager
Nancy Clark HFD-4447 301-796-1187
Division of Medication Errors and Technical Support
Director
Carol Holquist, R.Ph. HFD-4447 301-796-2360
Deputy Director
Denise Toyer, Pharm.D. HFD-4447 301-796-2360
Program Support Assistant
Elizabeth Moten HFD-4447 301-796-2360
Project Managers:
Scott Dallas HFD-4447 301-796-0144
Diane Smith HFD-4447 301-796-0538
OFFICE OF BIOSTATISTICS
Director
Robert O'Neil, Ph.D. HFD-700 301-796-1700
Administrative Support Assistant
Rose Rivera HFD-700 301-796-1700
Deputy Director
Edward Nevius, Ph.D. (Acting) HFD-700 301-796-1700
Management Officer
Zulema Miguele HFD-030 301-796-1700
Division of Biometrics I
Director Hsien Ming J Hung, Ph.D. 301-796-2439 WO(22)/Rm. 4238
Deputy Director Kooros Mahjoob 301-796-1115 WO(22)/Rm. 4236
Division of Biometrics II
Director
Thomas Permutt,Ph.D. (Acting) 301-796-2010 WO(22)/Rm. 3240
Division of Biometrics IV
Director
Mohammed Huque, Ph.D. 301-796-1800 WO(22)/Rm. 6232
Deputy Director
Daphne Lin,Ph.D. (Actg) 301-796-0751 WO(22)/RM. 6234
Division of Biometrics V
Director
Aloka G. Chakravaty,Ph.D. 301-796-1700
Division of Biometrics VI
Director
Stella Machado,Ph.D. 301-796-1700
OFFICE OF COUNTER-TERRORISM AND PEDIATRIC DRUG DEVELOPMENT
Director
Rosemary Roberts HFD-950 301-796-2210
Assistant
Pilar Martinez HFD-950 301-796-2210
Deputy Director (Acting)
Shirley Murphy,M.D. HFD-950 301-796-2210
Management Officer
Raya S. McCree HFD-950 301-796-2210
Division of Pediatric Drug Development
Director
Lisa Mathis, Actg. HFD-960 301-827-7337 MPN1/Rm. 226
Deputy Director (Actg)
Solomon Iyasu, M.D. HFD-950 301-827-7337 MPN1/Rm. 226
Division of Counter-Terrorism
Director
Mary E. Purucker, M.D. HFD-970 301-827-7711 MPN1/Rm. 229
Deputy Director
Brad Leissa, M.D. HFD-970 301-827-7711 MPN1/Rm. 229
OFFICE OF MEDICAL POLICY
Director
Robert J. Temple, M.D. HFD-040 301-796-2270 WO22/Rm.4212
Deputy Director
Rachel Behrman, M.D. HFD-040 301-796-2270 WO22/Rm.4212
Associate Director of Regulatory Affairs
Janet Norden HFD-040 301-796-1127 WO22/Rm.4202
Management Officer
Tammy Russell HFD-040 301-796-1045 WO22/Rm.4216
Division of Scientific Investigations
Director
Joanne Rhoads, M.D. HFD-045 301-594-0020 MPN/Rm. 103
Division of Drug Marketing, Advertising, and Communications
Director
Thomas W. Abrams HFD-042 301-796-1200
Deputy Director
vacant HFD-042 301-796-1200
OFFICE OF BUSINESS PROCESS SUPPORT
Director (Acting)
Steven Wilson, Dr.P.H. HFD-140 301-796-1000
Deputy Director
Vacant HFD-140 301-796-1000
Business Analysis and Reporting Staff
Michael Lanthier(Actg) HFD-141 301-796-1100
Regulatory Review Support Staff
Gary Gensinger HFD-142 301-796-1100
Division of Records Management
Director
Wendy Aaronson(Actg) HFD-143 301-796-0410
Deputy Director
Vacant HFD-143 301-796-0020
Information Services Team
Nasser Mahmud HFD-143 301-827-3880 PARK/Rm. 017
Records Repository Team
Vacant HFD-143 301-827-3877 PARK/Rm. 350
Records Quality Assurance Team
Gail Stone HFD-143 301-827-3874 PARK/Rm. 3012
OFFICE OF MANAGEMENT
Director
Russell J. Abbott HFD-010 301-594-6741 RKWLII/Rm. 7300
Special Assistant to the Director
Dawn Reid HFD-010 301-594-6741 RKWLII/Rm. 7300
Secretary
Christina Embrey HFD-010 301-594-6741 RKWLII/Rm. 7300
Deputy Director
Vacant HFD-010 301-594-6741 RKWLII/Rm. 7300
Management Officer
Rebecca E. Nalley HFD-060 240-453-6751 MPNVI/Rm. 2208
Division Of Management And Budget
Director
Robert Linkous HFD-050 240-453-6700 MPNVI/Rm. 2720
Deputy Director
Jennifer Whalen HFD-050 240-453-6700 MPNVI/Rm. 2720
Program Resource Management Branch
Rixie Scott HFD-050 240-453-6700 MPNVI/Rm. 2720
Management Analysis Branch
J.Richard Allen, Ph.D. HFD-050 240-453-6700 MPNVI/Rm. 2720
Division of Management Services
Director
John Emelio HFD-060 240-453-6800 MPN1/Rm. 2208
Deputy Director
Mary Baucum HFD-060 240-453-6800 MPN1/Rm. 2208
Program Management Services Branch
Patricia Gathers HFD-065 240-453-6768 MPNV1/Rm.2314
Interface Management Branch
Stephanie Hawk HFD-067 240-453-6790 MPNVI/Rm.2109
Special Assistant
Douglas Hamilton HFD-060 240-453-6800 MPN1/Rm. 2208
Division of Applications Development Services
Director
Timothy Mahoney HFD-075 301-827-3277 PARK/Rm. 320
Division of Infrastructure Management and Services
Director
Fred Gioetz (Actg) HFD-080 301-827-3278 PARK/Rm. 214
Deputy Director
Rodney Smith (Actg) HFD-080 301-827-3278 PARK/Rm. 214
OFFICE OF NEW DRUGS
Director
John Jenkins, M.D. HFD-020 301-594-3937 RWKLII/Rm. 7220
Secretary
Linda C. Hukle HFD-020 301-594-3937 RWKLII/Rm. 7207
Deputy Director
Sandra Kweder, M.D. HFD-020 301-594-3937 RWKLII/Rm. 7218
Senior Management Officer
Eldridge Coles HFD-022 301-443-5177 RWKLII/Rm. 1038
Associate Director for Pharmacology and Toxicology
David Jacobson-Kram,Ph.D,HFD-024 301-594-2569 RWKLII/Rm. 7214
Associate Director for Regulatory Affairs
Kim Colangelo HFD-020 301-594-3937 RKWLII/Rm. 7222
Associate Director for Guidance and Policy
Armando Oliva, M.D. HFD-020 301-594-3937 RKWLII/Rm. 7216
Director, Study Endpoints
Laurie Burke HFD-020 301-594-3937 RKWLII/Rm. 1029
Program Director, Pregnancy Labeling
Dianne Kennedy, M.D. HFD-020 301-594-3937 RKWLII/Rm. 1032
OFFICE OF DRUG EVALUATION I
Director
Robert J. Temple, M.D.(Actg)HFD-101 301-796-2270
Secretary
April Blount HFD-101 301-796-2270
Deputy Director
Rachel Behrman, M.D.(Actg) HFD-101 301-796-2270
Associate Director for Regulatory Affairs
Colleen LoCicero HFD-101 301-594-6758 RWKLII/Rm. 7201
Management Officer
Tammy Russell (Actg) HFD-101 301-443-5392 RWKLII/Rm. 7201
Division of Cardio-Renal Drug Products
Acting Division Director
Norman Stockbridge, M.D. HFD-110 301-796-2240
Deputy Director (Actg)
Thomas Marciniak, M.D. HFD-110 301-796-2240
Supervisory Project Manager
Ed Fromm HFD-110 301-796-2240
Division of Neurology Products
Director
Russell G. Katz, M.D. HFD-120 301-796-2250
Supervisory Project Manager
Robbin Nighswander HFD-120 301-796-2250
Division of Psychiatry Products
Thomas Laughren, MD. 301-796-2260
OFFICE OF DRUG EVALUATION II
Director
Robert Meyer, M.D. HFD-102 301-796-2310
Secretary
Velma Cunningham 301-796-2310
Deputy Director
Curtis Rosenbraugh HFD-102 301-796-2310
Secretary
Christopher Durant(Actg) HFD-102 301-796-2310
Associate Director for Regulatory Affairs
Leah Ripper HFD-102 301-796-2310
Management Officer
Thomas Cunningham HFD-102 301-796-2310
Division of Metabolic and Endocrine Drug Products
Director
David Orloff, M.D. HFD-510 301-796-2290
Secretary
Susan Marshall HFD-510 301-796-2290
Deputy Director
Mary Parks, M.D. HFD-510 301-796-2290
Supervisory Project Managers
Enid M. Galliers HFD-510 301-796-2290
Kati Johnson HFD-510 301-796-2290
Division of Pulmonary and Allergy Drug Products
Director
Badrul Chowdhury,M.D.(Actg) HFD-570 301-796-2300
Deputy Director
Eugene Sullivan,M.D. HFD-570 301-796-2300
Supervisory Project Manager
Sandra L. Barnes HFD-570 301-796-2300
OFFICE OF DRUG EVALUATION III
Director
Florence Houn, M.D. HFD-103 301-796-2100
Secretary
Gwendolynm Quan HFD-103 301-796-2100
Deputy Director
Julie Beitz, M.D. HFD-103 301-796-2100
Associate Director for Regulatory Affairs
Bronwyn E. Collier HFD-103 301-796-2100
Management Officer
Antoinette Mason (Actg) HFD-103 301-796-2100
Division of Reproductive and Urologic Drug Products
Director
Daniel Shames, M.D. HFD-580 301-796-2130
Deputy Director
Donna Griebel, M.D. HFD-580 301-796-2130
Division of Gastrointestinal and Coagulation Drug Products
Director
Brian Harvey HFD-180 301-796-2120
Secretary
Doris Garrison 301-796-2120
Deputy Director
Joyce Korvick HFD-180 301-796-2120
Supervisory Project Managers
Julie Ann DuBeau HFD-180 301-796-2120
Brian Strongin HFD-180 301-796-2120
OFFICE OF ANTIMICROBIAL PRODUCTS
Director
Ed Cox, M.D. (Acting) HFD-104 301-796-1300
Secretary
Lori Benner HFD-104 301-796-1300
Deputy Director
Jeff Murray, (Acting) HFD-104 301-796-1300
Associate Director for Regulatory Affairs
David Roeder HFD-104 301-796-1300
Management Officer
Dana Schuly (Acting) HFD-104 301-796-1300
Project Specialists
Lori Benner HFD-104 301-796-1300
Division of Anti-Infective Drug Products
Director
Janice Soreth, M.D. HFD-520 301-796-1400
Deputy Director
Wiley A. Chambers, M.D. HFD-520 301-796-1400
Supervisory Project Managers
Francis LeSane HFD-520 301-796-1400
Maureen Dillon-Parker HFD-520 301-796-1400
Division of Anti-Viral Drug Products
Director
Debra Birnkrant, M.D. HFD-530 301-796-1500
Deputy Director
Katie Laessig,M.D.(Acting) HFD-530 301-796-1500
Supervisory Project Managers
Anthony W. DeCicco HFD-530 301-796-1500
Virginia Behr HFD-530 301-796-1500
Division of Special Pathogen and Immunologic Drug Products
Director
Renata Albrecht, M.D. HFD-590 301-796-1600
Deputy Director
Steve Gitterman, M.D., Ph.D. HFD-590 301-796-1600
Supervisory Project Managers
Dana Willard HFD-590 301-796-1600
Judit Milstein HFD-590 301-796-1600
OFFICE OF NONPRESCRIPTION PRODUCTS
Director
Charles Ganley, MD HFD-105 301-796-2060
Deputy Director
Brian Harvey, MD, Ph.D. HFD-105 301-796-2060
Secretary
Norma Jiggetts HFD-105 301-796-0924
Associate Director
Susan Johnson, Pharm.D. HFD-105 301-796-0925
Management Officer
Merla Rae Matheny 301-796-0955
Division of Nonprescription Clinical Evaluation
Director
Andrea Leonard-Segal, M.D. 301-796-0940
Deputy Director
Joel Schiffenbauer, M.D. 301-796-1288
Program Specialist
Betty Clark 301-796-1186
Division of Nonprescription Regulation Development
Director
Susan Johnson,Pharm.D., Ph.D. (Acting) 301-796-2060
Division of Dermatologic and Dental Drug Products
Director
Stanka Kukich, M.D. HFD-540 301-796-2110
Supervisory Project Manager
Mary Jean Kozma Fornaro HFD-540 301-796-2110
Division of Anesthesia, Analgesic and Rheumatology Products
Director
Bob Rappaport HFD-550 301-796-2280
Secretary
Betty Clark HFD-540 301-796-2080
Deputy Director
Sharon Hertz, M.D. HFD-550 301-796-2080
Deputy Director
Wiley A. Chambers, M.D. HFD-550 301-796-2080
Supervisory Project Manager
Carmen DeBellas HFD-550 301-796-2080
Division of Nonprescription Regulation Development
Director
Susan Johnson,Ph.D. PharmD HFD-560 301-796-2090
Supervisory Project Manager
David Hilfiker HFD-560 301-796-2090
Division of Nonprescription Clinical Evaluation
Director (Acting)
Andrea Leonard-Segal, MD 301-796-2080
Deputy Director
David Ross, M.D., Ph.D. HFD-106 301-796-2080
Pharmacology and Toxicology Staff
David Jacobson-Kram, PhD HFD-106 301-796-0900
Associate Director for Regulatory Affairs
Glen Jones HFD-106 301-796-0900
Management Officer
Julie Basore HFD-106 301-796-0900
OFFICE OF ONCOLOGY DRUG PRODUCTS
Director
Richard Pazdur, M.D. HFD-106 301-796-2340 WO 22/Rm. 2212
Secretary
Vacant
Deputy Director
Karen Weiss, M.D. HFD-106 301-796-2340 WO 22/Rm. 2208
Associate Director for Regulatory Affairs
Glenn Jones, Ph.D. HFD-106 301-796-2340 WO 22/Rm. 2200
Associate Director for Regulatory Science
vacant HFD-106 301-796-2340 WO 22/Rm. 2202
Management Officer
Julie Basore HFD-106 301-796-2340 WO 22/Rm. 2215
Division of Biological Oncology Products
Director
Patricia Keegan, M.D. HFD-106 301-796-2320 WO 22/Rm. 2320
Secretary
Rhonda Hill HFD-106 301-796-1367 WO 22/Rm. 2325
Deputy Director
Vacant
Supervisory CSO
Karen Jones HFD-106 301-796-2320 WO 22/Rm. 2306
Division of Drug Oncology Products
Director
Robert Justice, M.D. (Acting) HFD-106 301-796-2330 WO 22/Rm. 2212
Secretary
Vacant
Deputy Director
Vacant
Supervisory CSO
Frank Cross HFD-106 301-796-2330 WO 22/Rm. 2110
Supervisory CSO
Dorothy Pease HFD-106 301-796-2330 WO 22/Rm. 2104
Division of Medical Imaging and Radiopharmaceutical Drug Products
Director
George Mills, M.D. HFD-160 301-796-2050 WO 22/Rm. 2356
Secretary
Georgette Henry-Chambers HFD-160 301-796-1366 WO 22/Rm. 2371
Deputy Director
Rafel (Dwaine) Rieves, M.D. HFD-160 301-796-2050 WO 22/Rm. 2348
Supervisory Project Manager
Kyong Kang HFD-160 301-796-2050 WO 22/Rm. 2352
Division of Therapeutic Biological Internal Medicine Products
Director
Marc Walton, M.D. HFD-108 301-796-2320
Deputy Director
Ellis Unger HFD-108 301-796-2320
Secretary
Dave Berman HFD-108 301-796-2320
OFFICE OF PHARMACEUTICAL SCIENCE
Director
Helen Winkle 301-796-2400
Secretary
Vera Viehmann HFD-003 301-796-2400
Deputy Director
Keith Webber HFD-003 301-796-2400
Operation Staff
Christopher Cole HFD-003 301-796-2400
Science & Research Staff
Nakissa Sadrieh, Ph.D. 301-796-2400
Informatic and Computational Safety Analysis Staff
Joseph F. Contrera, Ph.D. HFD-901 301-796-1522
Program Activities Review Staff
Jon Clark 301-796-2400
Microbiology Team
David Hussong, Ph.D HFD-805 301-796-2470
Bovine Spongiform
Mike Gavini HFD-320 301-827-9053
Encephalopathy
Michael Folkendt 301-796-1900
Compendial Issues
Larry Ouderkirk HFD-354 301-796-2400
Computational Toxicology
R. Daniel Benz 301-796-2400
Microbiology Team
Container/Closure Integrity
David Hussong, Ph.D. 301-796-2400
Large Volume Parenterals
David Hussong, Ph.D. 301-796-2400
Microbial Limits
David Hussong, Ph.D. 301-796-2400
Microbiology (CMC & Sterility)
David Hussong, Ph.D. 301-796-2400
OBP, Division of Monoclonal Antibodies 301-827-0805
National Environmental Policy Act (NEPA)
Ranaan Bloom 301-796-2400
National Toxicology Program (NTP)
Joseph Contrera, Ph.D. 301-796-1522
Positron Emission Tomographyu (PET (CMC Microbiology)
David Hussong, Ph.D. 301-796-2400
Sterilization Process Development
David Hussong, Ph.D. 301-796-2400
Sterilization Tests (Release or Stability)
David Hussong, Ph.D. 301-796-2400
ANDA's
Neil Sweeney, Ph.D. 301-796-2400
Sterilization Validation (Microbiology Team)
David Hussong, Ph.D. 301-796-2400
Therapeutic Inequivalence Action Coordination Committee (TIACC)
Bob King 301-796-2400
Toxicology Database
Joseph Contrera, Ph.D. 301-796-1522
Toxicology Predictive Modeling
Edwin Matthews, Ph.D. 301-796-1706
US Pharmacopeia Liaison
Larry Ouderkirk 301-796-2400
OFFICE OF BIOTECHNOLOGY PRODUCTS
Director (Actg)
Steven Kozlowski, MD HFD-121 301-796-2390
Deputy Director (Actg)
Kathleen Clouse, Ph.D. HFD-123 301-827-0792 N29B/Rm. 4NN12
Division of Monoclonal Antiboidies
Deputy Director (Actg)
Kathleen Clouse, PhD. HFD-123 301-827-0850 N29B/Rm. 3NN04
Division of Therapeutic Proteins
Director
Amy Rosenberg, M.D. HFD-122 301-827-1790 N29A/Rm. 2D16
Deputy Director
Barry Cherney, Ph.D. HFD-122 301-827-1790 N29/Rm. 2D16
OFFICE OF NEW DRUG QUALITY ASSESSMENT
Director
Moheb M. Nasr, PhD. HFD-800 301-796-1900
Deputy Director
Chi-Wan Chem, Ph.D. HFD-800 301-796-1900
Associate Director Regulatory Science
Guiragos Poochikian, Ph.D. 301-796-1736
Associate Director for Biopharmaceutics
Arzu Selen,Ph.D. 301-796-1603
Program Support Specialist
Patricia O'Connor 301-796-1727
Supervisory Project Manager
Michael Folkendt 301-796-1670
Management Officer
Angela Poe 301-796-1735
Division of Pre-Marketing Assessment I
Director
Brian Fraser Ph.D. 301-796-1900
Branch Chief, Branch I
Ramesh Sood, Ph.D. 301-796-1466
Branch Chief, Branch II
Blair Fraser, Ph.D. (Acting) 301-796-1671
Project Manager
Scott Goldie 301-796-2055
Division of Pre-Marketing Assessment II
Director
Elaine Morefield, Ph.D. 301-796-1987
Branch Chief, Branch III
Moo-Jhong Rhee, Ph.D. 301-796-1440
Branch Chief, Branch IV
Norman Schmuff, Ph.D. 301-796-1454
Project Manager
Linda Athey 301-796-2096
Division of Pre-Marketing Assessment III & Manufacturing Science
Director
Rik Lostritto, Ph.D. 301-796-1697
Branch Chief, Branch V
Ravi Harapanhalli, Ph.D. 301-796-1676
Branch Chief, Manufacturing Science
Christine Moore, Ph.D. 301-796-1422
Project Manager
Karl Stiller 301-796-1993
Division of Post-Marketing Evaluation
Director
Eric Duffy, Ph.D. 301-796-1666
Branch Chief, Branch VII
James Vidra, Ph.D. 301-796-1767
Project Managers
Teshara Bouie 301-796-1649
Rebecca McKnight 301-796-1765
Branch Chief, Branch VIII
Hasmukh Patel, Ph.D. 301-796-1432
Project Managers
Susan Jenney 301-796-0062
Valerie Jimenez 301-796-1345
Robert Hummel 301-796-1981
OFFICE OF GENERIC DRUGS
Director
Gary J. Buehler HFD-600 240-276-9310 MPN4/Rm. 3020
Secretary
Patricia Downs HFD-600 240-276-9310 MPN4/Rm. 3010
Director for Science
Lawrence Yu, Ph.D. HFD-600 240-276-9310 MPN4/Rm. 3014
Deputy Director
Robert West HFD-601 301-827-5815 MPN2/Rm. E277
Associate Director for Medical Affairs
Dena Hixon, M.D. HFD-600 240-276-9310 MPN1/Rm. 2210
Management Officer
Patricia Littleton HFD-600 240-276-9322 MPN4/Rm. 3024
Division of Chemistry I
Director
Rashmikant Patel, Ph.D. HFD-620 301-827-5848 MPN2/Rm. E203
Division of Chemistry II
Director
Florence Fang, Ph.D. HFD-640 301-827-5849 MPN2/Rm. E270
Division of Chemistry III
Director
Vilayat Sayeed HFD-640 301-827-9275 MPN2/Rm. E13
Division of Bioequivalence
Director
Dale Connor, Pharm.D. HFD-650 301-827-5847 MPN1/Rm. 11
Division of Labeling and Program Support
Director
Peter Rickman HFD-615 301-827-5846 MPN2/Rm. N128
Microbiology Staff
Team Leader
Neil Sweeney, Ph.D. HFD-600 240-276-9310 MPN2/Rm. N124
OFFICE OF CLINICAL PHARMACOLOGY / OFFICE OF TRANSLATIONAL SCIENCES
Director
Lawrence J. Lesko, Ph.D. HFD-850 301-796-2450 WO/Rm. 4546
Program Support Specialist
Marchette Alexander 301-796-1497 WO/Rm. 4541
Associate Director
Vacant
Division of Clinical Pharmacology I
Director
Mehul Mehta 301-796-1573 WO/Rm. 3628
Division of Clinical Pharmacology II
Director
Chandra Sahajwalla 301-796-1599 WO/Rm. 4630
Division of Clinical Pharmacology III
Director
Capt. Dennis Bashaw 301-796-1502 WO/Rm. 4628
Division of Clinical Pharmacology IV
Director
John Lazar 301-796-1559 WO/Rm. 4614
Division of Clinical Pharmacology V
Director
Nam Atiqur Rahman 301-796-1591 WO/Rm. 3672
Deputy Director of Science
Shiew-Mei Huang, Ph.D. 301-796-1541 WO/Rm. 4554
Associate Director for Genomics
Felix Frueh, Ph.D. HFD-850 301-726-1530 WO/Rm. 4512
Director of Pharmacometrics
Joga Gobburu, Ph.D. (Acting) 301-726-1589 WO/Rm. 4526
Management Officer
Bonita Moore 301-796-2213 WO/Rm. 4554
OFFICE OF TESTING AND RESEARCH
Director
Lucinda Buhse, PhD HFD-003 301-594-2847 RKWLII/Rm. 7200
Deputy Director
Vacant HFD-003 301-594-2847 RKWLII/Rm. 7200
Management Officer
Charis Miller HFD-910 301-796-0202 WO64/Rm. 3066
Division of Product Quality Research
Director
Mansoor Khan, Ph.D. HFD-940 301-796-0016 WO64/Rm. 1070
Deputy Director (Actg)
Robbe Lyon, Ph.D HFD-940 301-796-0019 WO64/Rm. 1076
Division of Applied Pharmacology Research
Director (Actg)
Nakissa Sadrieh, PhD HFD-910 301-796-0078 WO64/Rm. 2022
Deputy Director
Joseph P. Hanig, Ph.D. HFD-902 301-796-0079 WO64/Rm. 2076
Laboratory of Clinical Pharmacology
Director
John Strong HFD-902 301-796-0119 WO64/Rm. 2022 NLRC/Rm. 223B
Division of Pharmaceutical Analysis
Director
Lucinda Buhse,Ph.D(Acting) HFD-920 314-539-2134 St. Louis, MO/Rm. 1002
Deputy Director (Actg)
Benjamin Westenberger. HFD-920 314-539-3869 St. Louis, MO/Rm. 1002
OFFICE OF TRAINING AND COMMUNICATION
Director
Nancy D. Smith, Ph.D. HFD-200 301-827-1495 PKLN/Rm. 12B45
Secretary
Victor Vail HFD-200 301-827-1652 PKLN/Rm. 12B45
Deputy Director
John Friel HFD-200 301-827-1494 PKLN/Rm. 12B45
Management Officer
Bobbi Jones HFD-200 301-827-1493 PKLN/Rm. 12B45
Asst. Management Officer
Kelly Phelan HFD-200 301-827-1245 PKLN/Rm. 12B45
Division of Training and Development
Director
Janice Newcomb HFD-220 301-827-1262 PKLN/Rm. 12B10
Secretary
Sonya Armstrong HFD-220 301-827-0997 PKLN/Rm. 12B10
Deputy Director
Iris Khalas HFD-220 301-827-3498 PKLN/Rm. 12B10
Division of Public Affairs
Director
Ellen Shapiro HFD-210 301-827-1667 PKLN/Rm. 12B31
Administrative Assistant
Paul Neff HFD-210 301-827-1244 PKLN/Rm. 12B31
Deputy Director
Anthony Sims HFD-210 301-827-1496 PKLN/Rm. 12B31
Division of Drug Information
Director
Barry Poole HFD-240 301-827-3454 PKLN/Rm. 12B05
Deputy Director
Mary Kremzner HFD-240 301-827-3470 PKLN/Rm. 12B05
Administrative Assistant
Barbara Palm HFD-240 301-827-7747 PKLN/Rm. 12B05
Division of Information Services
Director
Carol S. Cavanaugh HFD-235 301-827-5092 RKWL2/Rm. 1069
Deputy Director
Kathryn W. Kruse HFD-235 301-827-5236 RKWL2/Rm. 1069
OFFICE OF COMPLIANCE
Director
Deborah Autor,Esq. HFD-300 301-827-8910 MM2/Rm. 406
Deputy Director
Joe Famulare, Actg HFD-300 301-827-8910 MM2/Rm. 405
Program Support Specialist
Linda Hukle HFD-300 301-827-9070 MM2/Rm. 405
Assistant Director
Steven Silverman,Esq. HFD-300 301-827-8910 MM2/Rm. 406
Associate Director of Scientific and Medical Affairs
Jason Woo,M.D. HFD-300 301-827-8910 MM2/Rm. 402
Associate Director for Operations
Terri Rumble HFD-300 301-827-9002 MM2/Rm. 407
Special Assistant
Crystal King, Ph.D., M.G.A.(Actg) HFD-300 301-827-9003 MM2/Rm. 408
Management Officer
Pam Grant HFD-305 301-827-9069 MM2/Rm. 305
Division of New Drugs and Labeling Compliance
Director
Michael Levy, Esq. 301-796-3110 WO51/Rm. 5188
Acting Associate Directors
Francis Gail Bormel 301-796-3263
Jennifer Devine 301-796-3347
Deputy Director
Kathleen Anderson, Pharm.D. 301-796-3309 WO51/Rm. 5182
Secretary
Marva Ralph 301-796-3312 WO51/Rm. 5185
Project Management Officer
Maryann Munson 301-796-3308 WO51/Rm. 5180
Steven Lynn 301-796-3315 WO51/Rm. 5192
Carrie Mamphilly 301-796-3311 WO51/Rm. 5184
OTC Drugs Team
Robert Heller 301-796-3353 WO51/Rm. 5246
Internet and Health Fraud Team (VACANT)
Compounding Team
Samia Nasr 301-796-3409 WO51/Rm. 5170
New Drugs and Labeling Team
Tia Harper-Valezquez (Acting) 301-796-3301 WO51/Rm. 5171
Imports and Exports Team (Vacant)
Anthony Lee (Acting) 301-796-3319 WO51/Rm. 5198
Division of Manufacturing and Product Quality
Director
Nick Buhay (Actg) HFD-320 301-827-8940 MM2/Rm. 438
Deputy Director
Grace McNally (Actg) HFD-320 301-827-8940 MM2/Rm. 427
Associate Director (Recalls & Shortages)
Michael Smedley (Actg) HFD-3280 301-827-8997 MM2/Rm. 424
Secretary
Sheila Banks HFD-320 301-827-9075 MM2/Rm. 403
Project Management Officer
Kennerly Chapman HFD-320 301-827-9032 MM2/Rm. 434
Case Management and Guidance Branch
Frederick Blumenschein HFD-320 301-827-8941 MM2/Rm. 424
Case Management Team Leader
Teddy Lopez HFD-320 301-827-9023 MM2/Rm. 425
Guidance & Policy Development Team
Rick Friedman HFD-320 301-827-9031 MM2/Rm. 433
Investigations & Preapproval Compliance Branch
Branch Chief
Edwin Rivera-Martinez HFD-322 301-827-9021 MM2/Rm. 423
Pre-Approval Compliance & International Certificates/Submissions Team Leader
Coki Cruz HFD-322 301-827-9013 MM2/Rm. 418
Foreign Inspection Team Leader
John Dietrick HFD-322 301-827-9021 MM2/Rm. 417
Therapeutics Facilities Review Branch
Brenda Uratani (Actg) HFD-328 301-443-5133 RWKII/Rm. 1014
Investigations and Preapproval Compliance Branch
Edwin Rivera Martinez HFD-322 301-827-9021 MM2/Rm.423
Preapproval Compliance and International Certificates/Submissions Team
Concepcion Cruz HFD-323 301-827-9013 MM2/Rm. 418
Foreign Inspection Team
John Dietrick HFD-325 301-827-9021 MM2/Rm. 417
Division of Compliance Risk Management and Surveillance
Director
John W. Gardner, M.D., PH.D. HFD-330 301-827-8920 MM2/Rm. 307
Deputy Director
Jay Schmid (Actg) HFD-330 301-827-8929 MM2/Rm. 317
Risk Management and Strategic Problem Solving Team
Suzanne Barone HFD-330 301-827-8922 MM2/Rm. 310
Surveillance and Data Analysis Branch
Vacant
Surveillance Programs Team
Jay Schmid HFD-333 301-827-8929 MM2/Rm. 317
Data Analysis and Information Management Team
Brenda Wang HFD-335 301-827-8936 MM2/Rm. 321
Drug Registration & Listing Team
John Coburn HFD-330 301-827-8925 MM2/Rm. 313
Division of Scientific Investigations (DSI)
Director
Gary Della'Zanna,D.O., M.Sc. HFD-045 301-594-0020 MPNI/Rm. 103
Deputy Director
Joseph Salewski HFD-045 301-594-0020 MPNI/Rm. 1416
Good Clinical Practice Branch I
Constance Lewin, M.D. HFD-046 301-827-7279 MPNI/Rm. 1400
Good Clinical Practice Branch II
Leslie Ball, M.D. HFD-047 301-827-5455 MPNI/Rm. 1425
GLP/Bioequivalence Investigations Branch
C.T. Viswanathan, Ph.D. HFD-048 301-594-0613 MPNI/Rm. 1310
Back to Top
New York - Northeast Region Atlanta - Southeast Region
Diane Kolaitis Gary J. Dykstra
Food and Drug Administration Food and Drug Administration
HFR-NE1 HFR-SE1
158-15 Liberty Avenue 60 Eighth Street, NE
Jamaica, New York 11433-1034 Atlanta, Georgia 30309
(718) 662-5416 (404) 347-4266
FAX (718) 662-5434 FAX (404) 347-4349
Philadelphia - Central Region Dallas - Southwest Region
Susan M Setterberg Gary L. Pierce
Food and Drug Administration Food and Drug Administration
HFR-MA1 HFR-SW1
900 US Customhouse 7920 Elmbrook Drive, Suite 102
2nd and Chestnut Streets Dallas, Texas 75247-4982
Philadelphia, Pennsylvania 19106 (214) 655-8100 X111
(215) 597-8058 FAX (214) 655-8130
FAX (215) 597-5798
Chicago Central Region San Francisco - Pacific Region
Susan M Setterberg Brenda J. Holman
Food and Drug Administration Food and Drug Administration
HFR-MW1 HFR-PA1
20 N. Michigan Ave, Rm 510 Oakland Federal Bldg
Chicago, Illinois 60602 1301 Clay Street, Suite 1180-N
(312) 353-9400 Ext. 20 Oakland, California 94612-5217
(510) 637-3960X18
FAX (312) 886-1682 FAX (510) 637-3976
Back to Top
General calls from industry, general public and health professionals should be referred to:
CDER, Division of Communications Management, Drug Information
HFD-210, (301) 827-4573
Calls From Field Public Affairs Specialists (PASs)
CDER Public Affairs Liaison,
Cynthia Fitzpatrick
(301) 827-4570 (Main number)
CDER Division of Public Affairs
Trade Press Inquiries
Crystal Rice 301-827-1673
Karen Mahoney 301-827-1676
Back to Top Back to About CDER
Last updated: March 27, 2009 |