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, Events 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. For complete information and instructions on how to apply, please read the announcement. 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. Regulatory Affairs: NHLBI Small Biz Hangouts: Conquering the (Regulatory) Basics Tuesday, December 16, 2014, 2:00-3:00 p.m. ET This is an overview of biologics product development and regulation featuring Marcia Gaido, PhD, RAC, Principal, MGReg Consulting, LLC. Join by Google at http://bit.ly/1jApiAl or YouTube at http://bit.ly/RS0Oaf. Previous Events Education and Training 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. 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 Advancing 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.