About FDA

The CDER Reference Guide

General Information
FDA Organization Charts
Telephone Numbers Frequently Requested of the FDA
Regional Food and Drug Directors
FDA Acronyms and Abbreviations

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 Communications
Division of Drug Information
10001 New Hampshire Ave
Hillandale Bldg., 4th Floor
Silver Spring, MD 20993

Main FDA for general inquiries: 1-888-INFO-FDA (1-888-463-6332)
Drug Information: 301-796-3400 (8:00 a.m. - 4:30 p.m. Eastern Time)
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) 796-3191
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) 796-3100
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) 796-1300
Electronic Signatures                                   (301) 827-8907
Electronic Submissions (CDER)                           (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

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