Science & Research
Resources for You
Driving Biomedical Innovation: Initiatives for Improving Products for Patients Advancing Regulatory Science for Public Health Critical Path Report on Key Achievements in 2009 (PDF - 381KB)The Critical Path Report -- 2008 (PDF - 316KB)Critical Path Opportunities for Generic Drugs Critical Path Opportunities List - March 2006 (PDF - 485KB)March 2004 - Challenge and Opportunity on the Critical Path to New Medical Products (PDF - 1MB)
Advancing Regulatory Science
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.
On February 24, 2010, FDA launched its Advancing Regulatory Science Initiative (ARS), 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, ARS is expanding its scope to encompass every dimension of regulatory science. The goals of the Advancing Regulatory Science Initiative, highlighted below, span the breadth of FDA's regulatory activities.
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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. |
Regulatory Science Initiative Plan
Advancing Regulatory Science for Public Health
A Framework for FDA's Regulatory Science Initiative
Regulatory Science-Related Agency Activities
- Accelerating Delivery of New Treatments to Patients
- Improving Pediatric and Child Care
- Developing Products for Global Infectious Disease and Bioterrorism
- Enhancing Safety and Health Through Informatics
- Protecting the Food Supply
- Meeting the Challenges for Regulating Tobacco
- Modernizing Toxicology To Improve Public Health
Spotlight
- Register Now for FDA's Nov. 13-15, 2012 Clinical Investigator Training Course!!!
- Broad Agency Announcement: FDA Solicits for Research and Development to Support Regulatory Science and Innovation
- Watch the full Webcast of the April 16 Reproductive and Developmental Toxicology Workshop: From In Vivo to In Vitro!
Centers of Excellence in Regulatory Science and Innovation (CERSI) - FDA Voice Interviews Dr. Jesse Goodman on Toxicology Collaboration: Human on a Chip