Regulatory Science

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

The 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

News, Events, and Funding Opportunities

U. S. Food and Drug Administration Regulatory Science Student Internship Program

The U. S. Food and Drug Administration (FDA) has developed a new summer internship for graduate students who are interested in the field of regulatory science. Participation in this Internship will give students a unique opportunity to develop and implement a mentored individual development plan and a project in regulatory science. Students will be able to take FDA courses, lectures and seminars, interact with senior FDA staff and explore FDA career possibilities. For more information and an application form, click here. Deadline for applications is Thursday, May 15, 2014. A compilation of other student programs, post-graduate fellowships, and faculty and senior scientist programs links are also available, click here.

Reagan-Udall Foundation Alzheimer's Disease Regulatory Science Fellowship

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.

Regulatory Science Competition Spurs Innovation

A new UR contest encourages students and the whole UR research community to think about turning advances in basic and applied sciences more quickly – and safely – into new ways to improve health. The UR Office of Research Alliances and the CTSI hosted and sponsored the inaugural “America’s Got Regulatory Science Talent Competition.” The award went to David Brodell for his proposal on the process of determining whether an experimental drug will be toxic to the heart could be transformed through advanced computational simulations. Read more in the CTSI Stories Blog

Previous Events

"America's Got Regulatory Science Talent" Competition

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. For more general information, last year's announcement is available here.

Burroughs Wellcome Fund Innovation Regulatory Science Awards

The Innovation in Regulatory Science Awards provide $500,000 over five years to support investigators who are addressing research questions that will lead to innovation in Regulatory Science, with ultimate translation of those results into improving the regulatory process. The pre-proposal deadline is Novermber 18, 2013. For more information, click here.

U.S. Food and Drug Administration Broad Agency Announcement (BAA): Advanced Research and Development for Regulatory Science

The U.S. Food and Drug Administration (FDA) accepts applications on a rolling basis for research and development projects to support Regulatory Science and innovation. FDA anticipates that research and development activities awarded under this Broad Agency Announcement (BAA) will serve to advance scientific knowledge to accomplish its mission to protect and promote the health of our nation. For more information, click here.

FDA–NIH/NCI Interagency Oncology Task Force (IOTF) Fellowship Program

The National Cancer Institute (NCI), National Institutes of Health, and U.S. Food and Drug Administration (FDA), U.S. Department Health and Human Services (DHHS) are offering fellowship training for Ph.D.s, M.D.s, and M.D./Ph.D.s or their equivalents in cancer-related scientific research and research-related regulatory review. For more information, click here.

Center for Biologics Evaluation and Research (CBER): Jobs and Fellowships

CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines, and therapeutics. Employment opportunities offer competitive salaries and excellent benefits. For more information, click here.

Biomedical Engineering Seminar Series: “FDA Engineers’ Roles in Regulatory Science and the Development of Standards”

Tuesday, November 12, 2013

Mitchell Shein, Chief of the Implantable Electrophysiological Devices Branch in the Division of Cardiovascular Devices at the FDA, presented “FDA Engineers’ Roles in Regulatory Science and the Development of Standards” on Tuesday, November 12th. The discussion included an overview of the standards development process, as well as an open discussion on engineer’s roles in Regulatory Science and the development of device standards at the Center for Devices and Radiological Health in the U.S. Food and Drug Administration. For more information, click here.

Regulatory Science Seminar by Larry Lesko, Ph.D., F.C.P.

Monday, November 4, 2013

"Model-Based Drug Development: A Biomedical Process for Clinical and Translational Science" was presented by Dr. Larry Lesko, Director, Center for Pharmacometrics and Systems Pharmacology, University of Florida; and Former Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA.

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.