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

.

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

Deviation Reports

• Biological Product Deviation Reporting - bp_deviations@fda.hhs.gov
• Deviations in manufacturing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) - hctp_deviations@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.
 

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

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

• For additional information see CBER SOPP 8101.3 - Appendix 1 Procedures for Requesting Speakers from FDA/CBER for Meetings, Conferences, Panels, Workshops, etc.

Mailing Address