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Center for Biologics Evaluation and Research

View detailed information about Center for Biologics Evaluation and Research, including compliance records, people, and regulatory data.

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Office Profile

Comprehensive profile of Center for Biologics Evaluation and Research, including its role, location, and regulatory activities.

People (8)
Scott A. Nabe
FDA_ASSOCIATED_PERSON
Gladys Rodriguez
FDA_ASSOCIATED_PERSON
Jose F. Pedró
FDA_ASSOCIATED_PERSON
Michael L. Forster
FDA_ASSOCIATED_PERSON
James L. Cloar III
FDA_ASSOCIATED_PERSON
Karen Bernard
FDA_ASSOCIATED_PERSON
Carmelo Rosa
FDA_ASSOCIATED_PERSON
Richard W. Berning
INVESTIGATOR
Records (20)
WARNING_LETTER - Octapharma USA, Inc.

Biologics • April 10, 2012

WARNING_LETTER
WARNING_LETTER - Ovation Pharmaceuticals, Inc.

Biologics • August 25, 2008

WARNING_LETTER
WARNING_LETTER - CSL Behring GmbH

Biologics • September 9, 2025

WARNING_LETTER
WARNING_LETTER - Eclipse Aesthetics LLC

Biologics • October 27, 2015

WARNING_LETTER
WARNING_LETTER - Zizion Group LLC

Biologics • March 12, 2015

WARNING_LETTER
WARNING_LETTER - HomeopathyStore.com

Biologics • July 6, 2015

WARNING_LETTER
WARNING_LETTER - Arteriocyte Medical Systems Inc

Biologics • December 23, 2009

WARNING_LETTER
WARNING_LETTER - Cellebration LLC

Other • September 12, 2025

WARNING_LETTER
WARNING_LETTER - Sanofi Winthrop Industrie

Biologics • July 12, 2012

WARNING_LETTER
WARNING_LETTER - www.sharco.tv

Biologics • December 9, 2009

WARNING_LETTER
WARNING_LETTER - SmartPractice Denmark ApS

Biologics • May 3, 2013

WARNING_LETTER
WARNING_LETTER - Baxter International Inc.

Biologics • August 3, 2010

WARNING_LETTER
WARNING_LETTER - Calibrate IV Hydration

biologics • October 1, 2026

WARNING_LETTER
WARNING_LETTER - Tides Medical LLC

biologics • October 1, 2026

WARNING_LETTER
WARNING_LETTER - Beaute Bounty

biologics • September 1, 2026

WARNING_LETTER
WARNING_LETTER - NexCell Scientific Inc

biologics • February 5, 2026

WARNING_LETTER
WARNING_LETTER - Genetrace

Devices • January 8, 2026

WARNING_LETTER
WARNING_LETTER - Genovate

Devices • January 8, 2026

WARNING_LETTER
WARNING_LETTER - Germaphobix

Biologics • January 1, 2026

WARNING_LETTER
483 - BDR Pharmaceuticals International Private, Ltd.

drugs • November 20, 2025

483

Showing 1 to 20 of 20 records

Guidance Documents (10)
Recommendations for Reducing the Risk of Transfusion-Transmitted Hepatitis B Virus: Guidance for Industry
Guidance
Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products
Guidance
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management
Guidance
Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy: Guidance for Industry
Guidance
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Guidance for Industry
Guidance
Potency Assessment of Active Immunotherapy Products
Guidance
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing
Guidance
Submitting Continuous Glucose Monitoring Data in Clinical Trials
Guidance
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for Industry
Guidance
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing
Guidance
Related Offices (5)
Office of Compliance Intervention and Consultation
OCIC
Acting Division Director
Bureau of Environmental Health
Division of Nonprescription Drug Products
Division of Reproductive and Urologic Products
Office Information

Name

Center for Biologics Evaluation and Research

Abbreviation

CBER

Country

USA

Postal Code

20993-0002

State/Province

Maryland

City

Silver Spring

Address

10903 New Hampshire Avenue

Office Website

Visit Website

ID: dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d

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Contact
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370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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