Moving Regulatory Science into the 21st Century
Regulatory Science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.
In 2010, FDA launched its Advancing Regulatory Science Initiative, building on the achievements of existing Agency programs, like the Critical Path Initiative's groundbreaking efforts to transform the way medical products are developed, evaluated, and manufactured.
Recognizing the success of the Critical Path model, the Advancing Regulatory Science Initiative is expanding its scope to encompass every dimension of regulatory science. The Initiative's goals, highlighted below, span the breadth of FDA's regulatory activities.
FDA has developed a strategic plan for regulatory science, the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products.
This document outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health.
View speech by FDA Commissioner Margaret A. Hamburg, M.D.
National Press Club, Oct. 6, 2010
Regulatory Science Initiative Plan
Advancing Regulatory Science for Public Health
A Framework for FDA's Regulatory Science Initiative