Regulatory Science AGRST Competition! "America's Got Regulatory Science Talent" Competition Deadline for applications: November 13, 2015 at 5 p.m. EST 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. This is the 3rd annual competition that will be held at the University of Rochester campus on Tuesday, December 8th. Complete information and instructions on how to apply are in the announcement. "Advancing a Vision for Regulatory Science Training" article Dr. Joan Adamo and Dr. Scott Steele published an article in the Clinical and Translational Science Journal that discusses 11 thematic areas of training that contribute to regulatory science. Read more in the CTSI blog. Drs. Adamo and Steele are also coordinating the CTSI Seminar Series starting on September 8th on "Advancing Regulatory and Transitional Science: Research, Training and Partnerships". 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 FDA First-ever Patient Engagement Advisory Committee Posted on 9/18/15 by Nina L. Hunter, PhD and Robert M. Califf, MD Patients and their care partners participate in decision-making and priority-setting in all aspects of health care...continue reading... FDA's Commissioner's Fellowship Program: 2015 Science Board Report to the FDA available now. FDA Science Moving Forward, the progress report to the FDA Science Board, was recently released. FDA's 2015 Office of Regulatory Science and Innovation Science Symposium, April 27, 2015 Corey Hoffman, winner of the 2nd annual "America's Got Regulatory Science Talent" competition presented his project to the FDA's 2015 Office of Regulatory Science and Innovation Science Symposium in Maryland. Read more about his project here and the complete webcast of the Symposium is now available at: ORSI Symposium. FDA Voice: More Collaboration, Research Needed to Develop Cures Posted on July 16, 2015 by Robert Califf, MD New report compares diseases where there is a robust pipeline of new therapies with diseases that have few known treatments or cures. Read more... Regulatory Science Fellowship in Graduate Medical Education: Clinical Trial Methodology and Regulatory Science This is a two-year NIH/NINDS/FDA fellowship in neurology clinical reseach at the NIH Clinical Center in Bethesda and neurology clinical research regulatory review at the FDA Federal Research Center in Silver Springs (Maryland). Applications are accepted on a rolling basis with fellowships starting July 1st. For more information and to apply, read here. 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.