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U.S. Department of Health and Human Services

About FDA

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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 301-827-2000.
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

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

Deviation Reports

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 (HFM-4)
Center for Biologics Evaluation and Research
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448

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

800-835-4709
301-827-1800

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

Mailing Address

Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration
1401 Rockville Pike, Suite 200N
Rockville, MD 20852-1448