Regulatory Science "America's Got Regulatory Science Talent" Competition! Eight University of Rochester teams competed on Tuesday, February 10th for the chance to win the opportunity to advance their regulatory science idea and present it to the FDA this year. Winners to be announced soon! 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 Regulatory Science Fellowship in Graduate Medical Education: Clinical Trial Methodology and Regulatory Science This is a two-year NIH/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 now being accepted for 2015. For more information and to apply, read here. FDA and CERSI Co-sponsored Conference: Strategies to Improve Capture and Availability of Information in Health Care Databases Used in Drug Safety Evaluation Studies Workshop. When: Monday, May 4, 2015, 8:30 a.m. Where: Food and Drug Administration, Silver Spring, MD For more information, visit here. Smart Ways to Manage Health Need Smart Regulation by Bakul Patel and Jeffrey Shuren of FDA's Center for Devices and Radiological Health FDA finalized guidance on medical device data systems (MDDS) and is working on guidance for low-risk devices and medical device accessories. Posted February 6, 2015 on FDA Voice. Read more FDA Considering How to Tailor its Oversight for Next Generation Sequencing by Margaret A. Hamburg, MD. FDA is weighing the appropriate regulatory approach to advances in technology that allow physicians to obtain information on large segmens of a patient's genetic makeup quickly. Posted January 30, 2015 on FDA Voice. Read more... 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.