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Foreign Regulatory Seminar (Web-Based): CBERs Regulation of Biologics

Introduction

The Center for Biologics Evaluation and Research (CBER) is pleased to provide a web-based informational program to explain CBER’s oversight of biological products in the United States.  It is intended primarily for the benefit of our foreign regulatory counterparts, however, the information may be of interest to other parties as well.

This outreach program was generated from a live program originally held in October 2009. With modest editing, staff developed this web-based production in order to more effectively reach a broader audience than was possible by offering in-person programs. The training material was updated in 2019 to stay abreast of legislative and organizational changes that occurred since the program was first developed.

Many questions regarding CBER and its oversight of the products under its jurisdiction can be answered by viewing the program. However, CBER has generated an email address that can be used to submit any specific questions that might not be addressed by the program content. Email questions or comments to: ForeignRegOutreach@fda.hhs.gov.

CBER appreciates your interest in the U.S. regulation of biologics. Thank you.

Introduction and Overview of The Center for Biologics Evaluation and Research (CBER)

An introduction to the FDA’s Center for Biologics Evaluation and Research providing an overview of its regulatory mission, relating the complexity of biologic products regulated, and discussing examples of applied scientific research conducted in support of U.S. and global public health.

Peter Marks, M.D., PhD
Director
Center for Biologics Evaluation and Research
U.S. Food and Drug Administration

New At CBER: Regulatory and Organizational Updates

Discussion of the organizational changes within CBER, and the updated regulatory approaches from the perspective of each CBER product office, reflecting CBER’s current thinking on the regulation of biologics. This includes specific updates to the existing information contained in the foreign regulatory seminar program.

 

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