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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Introduction
The Food and Drug Administration (FDA)
is organized into various components which each have seperate responsibilities.
Each component of FDA has an office to provide technical assistance to manufacturers.
This includes assistance to manufacturers of human drugs, animal drugs and devices,
biological products, food products and cosmetics. These offices can be contacted
for technical assistance for products regulated by the FDA other than medical
devices.
Human Drug Products:
Center for Drug Evaluation and Research (CDER)
Office of Training and Communication
Division of Drug Information (HFD-240)
5600 Fishers Lane, Room 12B-05
Rockville, MD 20857 U.S.A.
Telephone Number: 301-827-4573
Fax Number: 301-827-4577
CDER Home Page: http://www.fda.gov/cder
Email Address: druginfo@cder.fda.gov
Biological Products:
Center for Biologics Evaluation and Research (CBER)
Office of Communication, Training and
Manufacturers Assistance (HFM-43)
1401 Rockville Pike, Room 200N
Rockville, MD 20852-1448 U.S.A.
Telephone Number: 301-827-2000 or 800-835-4709
Fax Number: 301-827-3843
Fax-On-Demand: 888-223-7329 or 301-827-3844
CBER Home Page: http://www.fda.gov/cber
Email Address:
Manufacturers Assistance and Technical Training Team: MATT@.cber.fda.gov
Consumer & Health Professional Assistance:. OCTMA@cber.fda.gov
Animal Drugs and Devices:
Center for Veterinary Medicine (CVM)
Communications Staff
7519 Standish Place, HFV-12
Rockville, Maryland 20855
Telephone Number: 301-827-3800
Fax Number: 301-827-4065
CVM Home Page: http://www.fda.gov/cvm
Email Address: CVMHomeP@cvm.fda.gov
Food Products and Cosmetics:
Center for Food Safety and Applied Nutrition (CFSAN)
Outreach and Information Center
5100 Paint Branch Parkway, HFS-555
College Park, MD 20740-3835
Telephone Number: 1-888-SAFEFOOD (1-888-723-3366)
Telephone Number: 301-436-2600
Fax Number: 301-436-2618
CFSAN Home Page: http://www.cfsan.fda.gov/
Email Address: oco3@cfsan.fda.gov
Updated 6/30/2004
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