Small Business Guide to FDA
(last revised on 02/04/08)
FDA CENTERS' SMALL BUSINESS CONTACTS
Center Small Business Contact Person - When you have an inquiry that
requires highly specialized assistance, such as information to be submitted
in a new drug application, or if you are requesting a meeting with someone
in headquarters, you may save time by directly calling the small business
contact person in the appropriate center. The people listed below can
also send you a wide variety of informational materials or audiovisuals:
Center for Drug Evaluation and Research
Office of Training and Communication (HFD-210)
Ron Wilson, Director
Small Business Assistance
E-mail ronald.wilson@fda.hhs.gov
5600 Fishers Lane, Room 12B45
Rockville, MD 20852
Phone - (301) 827-1694
FAX - (800) 872-3056
CDER Ombudsman
Warren Rumble (Acting)
Phone - 301-594-5490
FAX - 301-827-4312
E-mail - ombudsman@cder.fda.gov
Small Business Assistance for drug firms can be accessed from the
Center for Drug Evaluation and Research at http://www.fda.gov/cder/about/smallbiz/default.htm.
Center for Biologics Evaluation and Research
Division of Manufacturers Assistance and Training (HFM-42), matt@cber.fda.gov
1401 Rockville Pike, Suite 200N
Rockville, MD 20857-1448
Phone - (301) 827-2000
FAX 301-827-3079
Voice Information System - (301) 827-1800 (1-800-835-4709)
Office FAX - (301) 827-3843
CBER Ombudsman
Sheryl Lard Whiteford
Phone - 301-827-0373
FAX - 301-827-0440
E-mail - sherry.lard@fda.hhs.gov
Center for Food Safety and Applied Nutrition
Industry Outreach Team
5100 Paint Branch Parkway
College Park, MD 20740-3835
Phone - (301) 436-2600
EMail - OCO3@cfsan.fda.gov
Center for Devices and Radiological Health
John F. Stigi, Director
Division of Small Manufacturers, International and Consumer Assistance (HFZ-220),
http://www.fda.gov/cdrh/devadvice/
Room 130C
1350 Piccard Dr.
Rockville, MD 20850
Email - dsmica@fda.hhs.gov
Phone - (1-800) 638-2041 or 240-276-3150
Fax - (240) 276-3151
The Division of Small Manufacturers, International and Consumer
Assistance (DSMICA), established in the Center for Devices and Radiological
Health, provides technical and other non-financial assistance to small
medical device manufacturers. Although DSMICA personnel are located
in headquarters, they routinely provide regulatory guidance to industry
regarding medical device and radiation-emitting products. DSMICA also
provides assistance to firms by conducting or participating in workshops. http://www.fda.gov/cdrh/dsma/workshop.html
Center for Veterinary Medicine
Joanne M. Kla, joanne.kla@fda.hhs.gov
Consumer Safety Officer
Communication Staff (HFV-l2)
Room N428 Metro Park North #2
7519 Standish Place
Rockville, MD 20855-2773
Phone - (301) 827-3806
FAX - (301) 594-4512
CVM Ombudsman
Marcia K. Larkins
Phone - 301-827-4535
FAX - 301-827-3957
E-mail - marcia.larkins@fda.hhs.gov
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