U.S. Government Agencies: U.S. Food and Drug Administration
Headquarters
10903 New Hampshire Avenue
Silver Spring, MD 20903
Phone: (888) INFO FDA (888 463 6332)
Website: http://www.fda.gov
Primary Contacts
Office of Regulatory Affairs
Richard H. Barnes
Director, Office of Regulatory Affairs (ORA)
Food and Drug Administration
5600 Fishers Lane, Room 12-07
Rockville, MD 20857
Phone: 301.827.6906
Fax: 301.443.2143
Website: http://www.fda.gov/ora/compliance_ref/rpm/default.htm
Center for Biologics Evaluation and Research (CBER)
Mary Anne Malarkey
Director, Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448
Phone: 301.827.6190
Fax: 301.594.0940
Email: [email protected]
Website: http://www.fda.gov/cber/
Center for Devices and Radiological Health (CDRH)
Carol Herman
Director, Standards Management
Center for Devices and Radiological Health (CDRH)
Food and Drug Administration
1350 Piccard Drive
Rockville, MD 20850-4307
Phone: 240.276.8715
Fax: 240.276.3151
Website: http://www.fda.gov/cdrh/index.html
Center for Drug Evaluation and Research (CDER)
Jane A. Axelrad
Associate Director, Office of Regulatory Policy
Center for Drug Evaluation and Research (CDER)
Food and Drug AdministrationB
5600 Fishers Lane, HFD-240
Rockville, MD 20857
Phone: 301.796.5400
Fax: 301.847.8752
Email: [email protected]
Website: http://www.fda.gov/cder/
Center for Food Safety and Applied Nutrition (CFSAN)
Roberta F. Wagner
Director, Office of Compliance
Center for Food Safety and Applied Nutrition (CFSAN)
Food and Drug Administration
5100 Paint Branch
College Park, MD 20740
Phone: 301.436.1714
Fax: 301.436.1714
Email: [email protected]
Website: http://www.cfsan.fda.gov/list.html
Center for Veterinary Medicine (CVM)
Daniel G. McChesney, Ph.D.
Director, Office of Surveillance and Compliance
Room 2673, Bldg MPN 4
7519 Standish Place
Rockville, MD 20855
Phone: 240.453.6830
Fax: 240.453.6880
Email: [email protected]
Website: http://www.fda.gov/cvm/default.html
Contact information for U.S. FDA employees may change. For the most current information:
Access U.S. FDA Organization Charts with contact information included.
General Overview of Agency Activities
The U.S.
FDA is an agency within the U.S. Department of Health and Human Services responsible
for protecting the public health by assuring the safety, efficacy, and security
of human and veterinary drugs, biological products, medical devices, the U.S. food
supply, cosmetics, and products that emit radiation. The FDA is also
responsible for advancing the public health by helping to speed innovations
that make medicines and foods more effective, safer, and more affordable; and
helping the public get the accurate, science-based information they need to use
medicines and foods to improve their health.
Learn more about individual branch offices and centers within the U.S. FDA.
Overview of Regulatory Activities
FDA is the federal agency responsible for ensuring that foods are safe, wholesome and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe. FDA also ensures that these products are honestly, accurately and informatively represented to the public.
Learn more about specific products that the U.S. FDA does regulate.
Learn more about products that the U.S. FDA either does not regulate or shares responsibility for regulating with other U.S. government agencies.
In order to fulfill their regulatory mission, the U.S. FDA is assisted by the following branch offices/centers:
Access the U.S. FDA Regulatory Procedures Manual.
Standards Used in Regulation and Procurement
FDA has incorporated several voluntary consensus standards into its technical regulations including standards developed by the following organizations:
In addition, FDA also formally recognizes voluntary consensus standards developed by:
The above lists may be incomplete and only attempt to name some of the standards developing organizations from which FDA has incorporated standards or that the agency formally recognizes.
Access the U.S. FDA Recognized Consensus Standards Database for voluntary consensus standards (market acceptance requirements) formally recognized by U.S. FDA
FDA recognizes a variety of conformity assessment approaches on a sector-by-sector basis. For more information, visit the following FDA resources:
Quick Links
International Contacts by Region
Africa
Beverly F. Corey, DVM
Staff Director for Asia, Africa, Middle East, and Capacity Building
U.S. Department of Health and Human Services
Food and Drug Administration
Office of International Programs
5600 Fishers Lane
Rockville, MD 20857-0001
Phone: 301.827.4480
Fax: 301.827.0003
Email: [email protected]
Americas
Matthew E. Eckel, JD
Acting Staff Director for Americas, Agreements, and Trade
U.S. Department of Health and Human Services
Food and Drug Administration
Office of International Programs
5600 Fishers Lane
Rockville, MD 20857-0001
Phone: 301.827.4480
Fax: 301.827.0003
Email: [email protected]
Asia Pacific
Beverly F. Corey, DVM
Staff Director for Asia, Africa, Middle East, and Capacity Building
U.S. Department of Health and Human Services
Food and Drug Administration
Office of International Programs
5600 Fishers Lane
Rockville, MD 20857-0001
Phone: 301.827.4480
Fax: 301.827.0003
Email: [email protected]
Europe
C. Michelle Limoli, Pharm. D.
Acting Staff Director for Europe Harmonization and Multilateral Affairs
U.S. Department of Health and Human Services
Food and Drug Administration
Office of International Programs
5600 Fishers Lane
Rockville, MD 20857-0001
Phone: 301.827.4480
Fax: 301.827.0003
Email: [email protected]
Middle East
Beverly F. Corey, DVM
Staff Director for Asia, Africa, Middle East, and Capacity Building
U.S. Department of Health and Human Services
Food and Drug Administration
Office of International Programs
5600 Fishers Lane
Rockville, MD 20857-0001
Phone: 301.827.4480
Fax: 301.827.0003
Email: [email protected]
Information on the U.S. FDA’s International Field Offices is being updated on a continual
basis. For more the most current information:
Access the main homepage for the Office of International Programs (OIP)
Access the main contact page for OIP
