CBER'S New Managed Review Process: A Managed and Integrated Regulatory Process Which is Continuous from Discovery to Post Marketing

Abstract

One of the goals of the Center for Biologics Evaluation and Research's (CBER's) strategic vision for 2004 is: “a managed and integrated regulatory process which is continuous from discovery through post marketing.” A strategy utilized to reach this goal is to apply the principles of managed review to the entire regulatory process. Managed review principles include the design of a review process which is streamlined, consistent, and efficient. Control of this review process is through performance goals in the form of review events which move the process forward. CBER has extended and enhanced its current Managed Review Process, thereby achieving this goal. This new Managed Review Process is presently being implemented in the center. It spans from discovery to post marketing, includes all regulatory mechanisms used for submission review and approval, proposes a change in the review team leadership structure, reinforces the importance of project management activities, and enhances performance goals through the addition of new review milestones and target dates.