About FDA

The CDER 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 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 Societydisclaimer icon (800) 227-2345

Application Integrity Policy (301) 796-3191

Biologics (CBER) (301) 827-2000

Breast Cancer Researchdisclaimer icon (800) 344-8564

Breast Implant Consumer Inquiries (CDRH) (301) 594-0485

CDER Executive Secretary (301) 797-3200

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

Diane Kolaitis
Food and Drug Administration
HFR-NE1
158-15 Liberty Avenue
Jamaica, New York 11433-1034
(718) 662-5416
FAX (718) 662-5434

Atlanta - Southeast Region

Gary J. Dykstra
Food and Drug Administration
HFR-SE1
60 Eighth Street, NE
Atlanta, Georgia 30309
(404) 347-4266
FAX (404) 347-4349

Philadelphia - Central Region

Susan M Setterberg
Food and Drug Administration
HFR-MA1
900 US Customhouse
2nd and Chestnut Streets
Philadelphia, Pennsylvania 19106
(215) 597-8058
FAX (215) 597-5798

Dallas - Southwest Region

Gary L. Pierce
Food and Drug Administration
HFR-SW1
7920 Elmbrook Drive, Suite 102
Dallas, Texas 75247-4982
(214) 655-8100 X111
FAX (214) 655-8130

Chicago Central Region

Susan M Setterberg
Food and Drug Administration
HFR-MW1
20 N. Michigan Ave, Rm 510
Chicago, Illinois 60602
(312) 353-9400 Ext. 20
FAX (312) 886-1682

San Francisco - Pacific Region

Brenda J. Holman
Food and Drug Administration
HFR-PA1
Oakland Federal Bldg
1301 Clay Street, Suite 1180-N
Oakland, California 94612-5217
(510) 637-3960X18
FAX (510) 637-3976

 

Contact FDA

Toll Free
(855) 543-3784, or
(301) 796-3400
Human Drug Information

Division of Drug Information (CDER)

Office of Communications

Feedback Form

10001 New Hampshire Avenue

Hillandale Building, 4th Floor

Silver Spring, MD 20993

Page Last Updated: 10/06/2014
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