About FDA

Resources for You

Contacts in the Center for Biologics Evaluation & Research (CBER)

Consumer Questions about Products - Please direct all consumer questions about biological products to ocod@fda.hhs.gov

Manufacturers Assistance - Please direct all manufacturers' assistance questions to Industry.Biologics@fda.hhs.gov. Manufacturers include blood and tissue banks, clinical investigators and other members of regulated industry.

Media Inquiries - Contact the Press Office

Technical Questions - Please direct all questions related to the functionality of this web site (problems getting to or viewing any of the information) to cberwebmaster@fda.hhs.gov

Emergency Use IND Requests -

For investigational biological products regulated by CBER, call 240-402-7800.
For all other investigational drugs, call 301-796-3400.
After working hours, call FDA's Office of Emergency Operations at 1-866-300-4374
or 301-796-8240

.

CDISC Standards (SDTM, ADaM) Inquiries - CBER.CDISC@fda.hhs.gov

Deviation Reports

Fatality Reporting - fatalities2@fda.hhs.gov

Tissue Registration - On-line Form: Tissue Establishment Registration Coordinator Contact or tissuereg@fda.hhs.gov

Blood Establishment Registration and Product Listing - On-Line BER Contacts Form

Automated E-Mail Lists - Subscription e-mail list service

CBER Ombudsman - For complaints regarding CBER's regulatory and managed review process and dispute resolution.
 

Mailing Address:

CBER Ombudsman
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Ave
WO71-7240
Silver Spring, MD 20993-0002

Voice Information System - Direct access to a Consumer Safety Officer or Public Affairs Specialist

800-835-4709
240-402-8010 

Requesting Speakers from CBER - Please direct all inquiries to cberspeakerliaison@fda.hhs.gov 

Mailing Address:

Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
 

 

Page Last Updated: 06/10/2014
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