For Industry
Small Business Contacts
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Are you a small business with questions about your FDA-regulated product?
Or, do you wonder if your product needs to be approved by the FDA?
Contact us!
Or, do you wonder if your product needs to be approved by the FDA?
Contact us!
1. U.S. Food and Drug Administration (FDA) Headquarters
Center for Biologics and Evaluation Research (CBER)
Office of Communication, Outreach and Development (OCOD)
Division of Manufacturers Assistance and Training (DMAT)
Manufacturers Assistance and Technical Training (MATT)
1401 Rockville Pike
Suite 200N/HFM-41
Rockville, MD 20852-1448
Phone: 301-827-1800
800-835-4709
Fax: 301-827-3843
Email: Industry.Biologics@fda.gov
Center for Drug and Evaluation Research (CDER)
Office of Communications
Division of Drug Information (DDI)
Brenda Stodart, PharmD
Small Business Assistance
10903 New Hampshire Avenue
WO-51- 2201
Silver Spring, MD 20990-0002
Phone:
Toll-free and International: 866-405-5367
Local: 301-796-6707
Fax: 301-847-8715
Email: CDERSmallBusiness@fda.hhs.gov
Center for Devices and Radiological Health (CDRH)
Office of Communication, Education and Radiation Programs (OCER)
Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
10903 New Hampshire Ave.
WO66-4613
Silver Spring, MD 20993
Phone: 301-796-7100 or 800-638-2041
Fax: 301-847-8149
Email: dsmica@fda.hhs.gov
Center for Food Safety and Applied Nutrition (CFSAN)
Division of Education and Communication
Communication and Coordination Branch, HFS-9
5100 Paint Branch Parkway
College Park, MD 20740-3835
Phone: 1-888-SAFE-FOOD
Email: Industry@fda.gov
Center for Tobacco Products (CTP)
9200 Corporate Boulevard
Rockville, MD 20850-3229
Phone: 1-877-CTP-1373 (1-877-287-1373)
Monday–Friday, 7:30 a.m.–6:00 p.m. EDT
E-mail: SmallBiz.Tobacco@fda.hhs.gov
Tobacco Small Business Assistance Website
Center for Veterinary Medicine (CVM)
7519 Standish Place
HFV-12
Rockville, MD 20855
Joanne Kla
Phone: 240-276-9300
Direct Line: 240-276-9129
Email: AskCVM@fda.hhs.gov
CVM Website
Office of International Programs (OIP)
White Oak Building 32
10903 New Hampshire Avenue
Silver Spring, MD 20993
Phone: 301-796-4600
E-mail: OIPCommunications@fda.hhs.gov
International Programs Website
2. FDA Regional and District Offices
Contacts for Regional and District Offices can also be found in the Investigations Operations Manual (IOM)
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3. FDA Small Business Representatives: Regional Contacts
Southwest Region (AR, CO, IA, KS, MO, NE, NM, OK, TX, UT, WY, US-Mexico Border Imports)
David Arvelo
Small Business Representative, (HFR-SW2)
Food and Drug Administration
4040 N. Central Expressway, Suite 900
Dallas, TX 75204
Phone: (214) 253-4952
Fax: (214) 253-4970
Email: david.arvelo@fda.hhs.gov
Northeast Region (CT, MA, ME, NH, NY, RI, VT)
Marilyn Rodriguez-Bohorquez
158-15 Liberty Avenue
Small Business Representative (HFR-NE17)
Food and Drug Administration
Jamaica, NY 11433-1034
Phone: (718) 662-5618
Fax: (718) 662-5434
Email: oranersbr@fda.hhs.gov
** If your state is not listed above, please contact the district office in your region under Section 2: FDA Regional and District Offices (above) or contact FDA Headquarters at 1-888-INFO-FDA (1-888-463-6332). Access more information about FDA at http://www.fda.gov/AboutFDA/default.htm
4. FDA Public Affairs Specialists: District Contacts
AK, WA, ID, MT, OR
Alan Bennett
(503) 671-9332
FAX (503) 671-9445
alan.bennett@fda.hhs.gov
FDA – Portland Resident Post
9780 SW Nimbus Avenue
Beaverton, OR 97008-7163
DE, PA
Anitra D. Brown
(215) 717-3004
FAX (215) 597-4660
anitra.brownreed@fda.hhs.gov
FDA – Philadelphia District Office
U.S. Customhouse, Rm. 900
2nd and Chestnut Streets
Philadelphia, PA 19106
DC, MD, VA, WV
Stephen King
(410) 779-5426
FAX (410) 779-5705
stephen.king@fda.hhs.gov
FDA – Baltimore District Office
6000 Metro Dr., Suite 101
Baltimore, MD 21215
IL
Lisa Misevicz
(312) 596-4217
FAX (312) 596-4187
FDAInquiriesIL@fda.hhs.gov
FDA- Chicago District Office
550 West Jackson Blvd.
Chicago, IL 60661
** If your state is not listed above, please contact the district office in your region under Section 2: FDA Regional and District Offices (above) or contact FDA Headquarters at 1-888-INFO-FDA (1-888-463-6332). Access more information about FDA at http://www.fda.gov/AboutFDA/default.htm
