Center for Biologics Evaluation and Research Strategic Plan for Regulatory Science and Research 2012-2016.

摘要

The CBER Strategic Plan for Regulatory Science and Research provides an overview of CBERs regulatory environment addressing the challenges of regulating biologics, the researcher-reviewer model used in CBER, and a description of the CBERs Research Management program. This information will provide an explanation and context for understanding CBERs research strategic goals, objectives, and strategies. The CBER Strategic Plan for Regulatory Science and Research details the types of research programs needed to address the challenging regulatory issues CBER will face in the next several years. The plan also describes the technology and infrastructure required to meet those needs and the steps we will take to put those resources to use efficiently and effectively.