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Center for Drug Evaluation and Research
Reference Guide

General Information

 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
5600 Fishers Lane, HFD-240
Rockville, MD 20857
Telephone number: (301) 827-4573 or 1-888-INFOFDA (463-6332).
E-mail address: druginfo@fda.hhs.gov

Telephone Numbers Frequently Requested of the FDA

                           

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
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FDA Key Officials Telephone Directory

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

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Regional Food and Drug Directors

                                
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 
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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

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Last updated: June 10, 2008

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