A Primer on CBER'S Regulatory Review Structure and Process

Abstract

The Center for Biologics Evaluation and Research (CBER) is the Food and Drug Administration (FDA) component responsible for ensuring the safety, potency, purity, and efficacy of biological products intended for use in the treatment, prevention, and cure of human diseases. As technology and medical research move forward in the development of novel biological products to aid in this endeavor, regulatory affairs and project management professionals are finding that they are interacting with CBER for the first time and that these interactions are increasing in frequency. The purpose of this article is to facilitate these interactions by providing a general understanding of CBER. Areas to be discussed include how CBER is unique as an FDA center, its areas of responsibility, the authority under which CBER operates, its regulatory mechanisms for review and approval, and the center's organizational structure. Also discussed is the manner in which CBER forms teams for review and approval of biological product submissions, responsibility of these team members, and management of CBER's review process.

Keywords

CBER Regulatory affairs Project management Biological products Review process

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