Small Business Guide to FDA
(last revised on 03/31/04)
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 wilsonr@cder.fda.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 - LARD@CBER.FDA.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, dsmica@cdrh.fda.gov
Division of Small Manufacturers, International and Consumer Assistance
(HFZ-220), www.fda.gov/cdrh/devadvice/
Room 130C
1350 Piccard Dr.
Rockville, MD 20850
Phone - (1-800) 638-2041
FAX - (301) 443-8818
CDRH Ombudsman
Les Weinstein
Phone - 301-827-7991
FAX - 301-827-2565
Email - OMBUDSMAN@CDRH.FDA.GOV
Center for Veterinary Medicine
Joanne M. Kla, jkla@cvm.fda.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 - mlarkins@cvm.fda.gov
In addition, 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 DSMA personnel
are located in headquarters, they routinely provide field assistance
to firms by conducting workshops and, at the request of the manufacturer,
making onsite visits.
|