"This document provides a broad overview of how CBER [Center for Biologics Evaluation and Research] seeks to fulfill its mission of protecting the public's health over the next three years. CBER has experienced a number of changes -- both internal and external -- since publication of the CBER Strategic Plan FY 2012-2016 four years ago. Some changes, such as new legislative mandates from the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), have expanded our responsibilities for ensuring access to safe and effective biological products. Other changes, such as the physical relocation and consolidation of all eight offices and associated laboratories to FDA [Food and Drug Administration] headquarters for the first time in the Center's history, have expanded opportunities for cross-Office and cross-Center collaboration to accomplish our mission. In 2015, CBER conducted a comprehensive review of the oversight and management of its regulatory science program and in 2016 gained a new Center Director and Deputy-- both of which entailed taking stock of current progress and identifying future needs and direction. For all these reasons, it was important for the Center to engage in a gap analysis that identifies where we currently are in fulfilling our mission, where we are headed in the next few years, and how we propose to get there."
United States Food and Drug Administration: http://www.fda.gov/