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  1. Center for Biologics Evaluation and Research (CBER)

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.


Table of Contents


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.

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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.

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Report a problem with FDA-regulated products

By phone:

For more details, see How to Report a Problem

Online:

 

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Stay informed

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Press Inquiries

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Freedom of Information Act requests

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Find a FDA staff member

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Comment on proposed regulations

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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

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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.).

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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

Visit Industry (Biologics) for more information.

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