Small
Business Guide to FDA
(last revised on 03/31/04)
WHO TO CONTACT FOR ASSISTANCE
Knowing whom to contact is the first step in obtaining information
you need. It may be helpful to keep in mind that FDA has five Centers,
five Regions, and 21 District
Offices within those regions. Reaching
the right office and, more importantly, the right person who has the
information you need, can sometimes be frustrating. This list of contacts
should help guide you in the right direction.
Whether you need information related to getting your product approved
and on the market, wanting an FDA speaker for your industry meeting,
or just need copies of FDA regulations, there are a number of sources
to which you can go for general assistance:
Small Business Representatives (SBRs) - FDA has Small Business Representatives
who help small businesses whose products are regulated by FDA. They
are located in five regions of the country: New York, Philadelphia,
Atlanta, Dallas, and Oakland.
OTHER LINKS WITH INFORMATION OR ASSISTANCE FOR INDUSTRY:
DRUGS - [CDER] - http://www.fda.gov/cder/about/smallbiz/default.htm
FOODS, DIETARY SUPPLEMENTS, COSMETICS - [CFSAN] - http://www.cfsan.fda.gov/~dms/industry.html
DEVICES - [DSMICA in CDRH] - http://www.fda.gov/cdrh/industry-asst.html or
"DEVICE ADVICE" - http://www.fda.gov/cdrh/devadvice
BIOLOGICS - [CBER] - http://www.fda.gov/cber/manufacturer.htm
ANIMAL PRODUCTS - [CVM] - http://www.fda.gov/cvm/faqs//faqs.html
These sites are available to deal with the special concerns and/or
provide helpful information to small firms and new businesses. They
provide information that clarifies how Agency laws and regulations
apply to various products or specific circumstances and suggest methods
of meeting these requirements. The SBRs can respond to your inquiries,
conduct or participate in workshops and conferences, or visit your
plant, at your request, to offer assistance.
All FDA speaker requests must be submitted through:
U.S. Food and Drug Administration
Office of Public Affairs
Program and Speaker Coordination Staff
5600 Fishers Lane, Room 15-06
Rockville, MD 20857
FAX 301-827-2847
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