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 In this section:

                Center for Biologics Evaluation and Research (CBER)

Center for Biologics Evaluation and Research (CBER)

                        CBER Offices & Divisions
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          CBER Product Jurisdiction
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          Center for Biologics Evaluation and Research (CBER)
          Contacts in the Center for Biologics Evaluation & Research (CBER)Center for Biologics Evaluation and Research (CBER) Contacts in the Center for Biologics Evaluation & Research (CBER)
  
  	
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    PrintAs of October 1, 2018, Regulatory Communications Via Secure Email
**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.
**Table of Contents**
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.back to top
**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 240-402-8020or
    
    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.back to top
**Report a problem with FDA-regulated products**
**By phone:**
    **Call 1-888-INFO-FDA (1-888-463-6332).**
      **Call the FDA Consumer Complaint Coordinator for your state or region.****For more details, see How to Report a Problem**
  Online:
    **MedWatch:** Use the MedWatch Online Reporting Form to report adverse events with human food and medical products or call 800-332-1088.
      **Safety Reporting Portal:** Use this online form to report problems with pet food, dietary supplements, and tobacco products. This form also accepts mandatory reports, such as the Reportable Food Registry for Industry.
      **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.

back to top
**Stay informed**
Subscribe to Podcasts and News Feedsback to top
**Press Inquiries**
Call 301-796-4540.
  Contact FDA’s Office of Media Affairs.back to top
**Freedom of Information Act requests**
Call CBER's FOIA line at 240-402-8008.
  FDA’s FOI Points of Contactback to top
**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).back to top
**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.back to top
**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 20993-0002Contact 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 20993-0002back to top
**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.).
back to top
**Requesting speakers**
Please direct all inquiries to cberspeakerliaison@fda.hhs.gov
Follow these procedures to request speakers for your event.
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**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 FormVisit Industry (Biologics) for more information.
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                                                                                  Content current as of:
      04/04/2023
              
              
Regulated Product(s)
		 BiologicsCenter for Biologics Evaluation and Research (CBER)

          
                        CBER Offices & Divisions
          CBER Vision & Mission
          CBER Reports
          CBER Ombudsman
          CBER Product Jurisdiction
          Jobs at CBER
 
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