CBER Contacts

 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:
[email protected]

Manufacturers Assistance:
[email protected]
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: [email protected]
• 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

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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 [email protected]. 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 [email protected]

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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• Content current as of:

  09/13/2024

Source