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 firstname.lastname@example.org
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 email@example.com
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
CDISC Standards (SDTM, ADaM) Inquiries - CBER.CDISC@fda.hhs.gov
- Biological Product Deviation Reporting - firstname.lastname@example.org
- Deviations in manufacturing of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps) - email@example.com
Fatality Reporting - firstname.lastname@example.org
Tissue Registration - On-line Form: Tissue Establishment Registration Coordinator Contact or email@example.com
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.
10903 New Hampshire Ave
Voice Information System - Direct access to a Consumer Safety Officer or Public Affairs Specialist
Requesting Speakers from CBER - Please direct all inquiries to firstname.lastname@example.org
- For additional information see CBER SOPP 8101.3 - Appendix 1 Procedures for Requesting Speakers from FDA/CBER for Meetings, Conferences, Panels, Workshops, etc.
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002