Science & Research

Advancing Regulatory Science

Moving Regulatory Science into the 21st Century 

Graphic depicting FDA-regulated products 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.

On February 24, 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 Advancing Regulatory Science Initiative goals, highlighted below, span the breadth of FDA's regulatory activities.

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Cover of the Strategic Plan for Regulatory Science Strategic Plan for Regulatory Science

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.


link to FDA report Advancing Regulatory Science for Public Health Advancing Regulatory Science for Public Health

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. disclaimer icon
National Press Club, Oct. 6, 2010


Regulatory Science Initiative Plan

Page Last Updated: 07/29/2015
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