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.
News, Events, and Funding Opportunities
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. Last week, the UR Office of Research Alliances and the CTSI hosted and sponsored the inaugural “America’s Got Regulatory Science Talent Competition.” Read more in the CTSI Stories Blog
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 information, including criteria and deadlines, click here.
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.
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.
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
The 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.
The FDA 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, 10/6/10)
To read more about advancing Regulatory Science, visit the FDA's webpage.
National Regulatory Science News and Events