Contacts in the Center for Biologics Evaluation & Research (CBER)
Call:
800-835-4709
240-402-8010
After the greeting, consumers and healthcare professionals press 1, manufacturers press 2, or for Freedom of Information Act requests press 3.
Write to:
Food and Drug Administration
Center for Biologics Evaluation and Research (CBER)
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Email:
Consumers:
ocod@fda.hhs.gov
Manufacturers Assistance:
Industry.Biologics@fda.hhs.gov
Manufacturers include blood, plasma and tissue banks, clinical investigators and other members of regulated industry who are developing pharmaceuticals derived from blood and blood components, vaccines, or cellular and gene therapies.
- Report an emergency
- Emergency IND requests
- Report a problem with FDA-regulated products
- Stay informed
- Press Inquiries
- Freedom of Information Act requests
- Find a FDA staff member
- Comment on proposed regulations
- Resolve a dispute or Request Product Jurisdiction
- Report a problem with this website
- Requesting speakers
- Industry contacts
Report an emergency
- If you are experiencing a life-threatening medical emergency, call 9-1-1.
- To report an emergency involving food, drugs, medical devices, dietary supplements, or cosmetics, call 1-866-300-4374 or 1-301-796-8240.
Emergency IND requests
INDs are unapproved products that need to be requested by a physician or health care provider.
- For investigational biological products regulated by CBER, call 240-402-8020 or
email: industry.biologics@fda.hhs.gov - 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.
Report a problem with FDA-regulated products
Online:
- MedWatch: Use the MedWatch Online Reporting Form to report adverse events with human food and medical products or call 800-332-1088.
- Report a Product Problem
- Vaccine Adverse Event Reporting System (VAERS): Report adverse events (possible side effects)that occur after the administration of vaccines licensed for use in the United States.
Stay informed
Press Inquiries
- Call 301-796-4540.
- Contact FDA’s Office of Media Affairs.
Freedom of Information Act requests
- Call CBER's FOIA line at 240-402-8008.
- FDA’s FOI Points of Contact
Find a FDA staff member
- Search the HHS employee directory (includes FDA employees).
- Contact an FDA Public Affairs Specialist (FDA’s community-based educators in your region or state).
Comment on proposed regulations
- View FDA’s proposed regulations and submit comments online (on Regulations.gov).
- How to comment on proposed regulations or submit petitions.
Resolve a dispute or Request Product Jurisdiction
- Contact the 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
- Contact the CBER Product Jurisdiction Officer (To identify the Center/Office responsible for regulating your product or submission)
Mailing Address:
CBER Product Jurisdiction Officer
Food and Drug Administration
Center for Biologics Evaluation and Research
10903 New Hampshire Ave
WO71-7240
Silver Spring, MD 20993-0002
Report a problem with this website
Send email to cberwebmaster@fda.hhs.gov. Indicate the web address (URL) where you encountered the problem and the type of issue (such as a broken link, problem downloading a document, etc.).
Requesting speakers
Please direct all inquiries to cberspeakerliaison@fda.hhs.gov
Follow these procedures to request speakers for your event.
Industry contacts
- As of October 1, 2018, Regulatory Communications Via Secure Email
- Imports: CBERimportinquiry@fda.hhs.gov
- Exports: CBERExportCert@fda.hhs.gov
- 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
- Fatality Reporting: fatalities2@fda.hhs.gov
- Tissue Registration: tissuereg@fda.hhs.gov, call 240-402-8369, or fax 301-595-1303
- Blood Establishment Registration and Product Listing: On-Line CBER Contacts Form
Visit Industry (Biologics) for more information.