Government and Academic Research Alliances

Regulatory Science

Transforming the way medical products are developed, evaluated, and manufactured

The U. S. Food and Drug Administration (FDA) defines Regulatory Science as “the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.” The FDA has launched a number of programs to enhance the translation of research into products that benefit patients and improve the success rate of safe and effective products. More information can be obtained through the FDA's strategic plan which explains the vision and importance of this exciting new field.

FDA-Strategic-Priorities-2014-2018: An Agency-level view of how FDA is addressing public health challenges and their mission and vision for the future. 

News and Funding Opportunities

"America's Got Regulatory Science Talent" Competition,
Deadline for applications: January 30, 2015

Want to see how your research can impact federal regulations? Want to discuss your ideas with the FDA? Join the "America's Got Regulatory Science Talent" Competition. The local competition will be held at the University of Rochester campus on Tuesday, February 10, 2015.  More general information will be out soon.

Regulatory Science Competition Winners for 2014 presented their ideas to the FDA.  University of Rochester student David Brodell and University of Maryland graduate student Chelsea Virgile traveled to the FDA campus in Maryland to present their winning "America's Got Regulatory Science Talent" competition proposals. Read more at Research@URMC blog.

On March 27, 2014, the Reagan-Udall Foundation for the FDA (RUF) announced the launch of a two-year fellowship in Alzheimer's Disease Regulatory Science. This opportunity is for MD's or DO's with several years of clinical experience working with patients with Alzheimer's Disease (AD). The fellowship focuses on identifying and creating opportunities for collaboration with AD scientific and patient advocacy communities to advance the development of new treatments. Applications are reviewed on a rolling basis with start dates between July and November 2014. For more information and how to apply, click here.

Events

FDA's National Medical Device Curriculum
The FDA offers a series of fictional case studies to help science and technology innovators understand FDA's medical device regulatory processes.  Case studies are free and take abouit 3 hours of student preparation.  Case Studies include: Regulatory Pathways for Medical Devices, Safety Assurance and Risk Management, Bringing a Device to Market, and more.  More information is available on the FDA website.  For questions, contact NMDC@fda.hhs.gov.

Previous Events

FDA Priority Areas

The FDA has identified the following as examples of priority areas in its plans to advance Regulatory Science:

  • Ensuring Readiness to Evaluate Innovative and Emerging Technologies
  • Improving pre-Clinical Assessments of Safety and Efficacy
  • Improving Clinical Studies and Evaluation
  • Supporting New Approaches to Improving Product Manufacturing and Quality
  • Harnessing Diverse Data through Information Sciences to Improve Health Outcomes
  • Strengthening Social and Behavioral Science to Help Consumers and Professionals Make Informed Decisions About FDA Regulated Products
  • Strengthening Social and Behavioral Science at the FDA by Enhancing Audience Understanding
  • Development of a New Prevention-Focused Food Safety System
  • Strengthening the Global Product Safety Net
  • Development of a Medical Countermeasures Structure to Protect Against Threats

 

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

The FDA outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health.

View the report.

View speech by FDA Commissioner Margaret A. Hamburg, M.D (National Press Club, 10/6/10)

 

To read more about advancing Regulatory Science, visit the FDA's webpage.