By Zivana Tezak PhD & Elaine Johanson – FDA is increasingly harnessing the power of supercomputers, the creative and collaborative culture of the scientific community, and novel approaches to technology.
Read More
By Rachel E. Sherman MD, MPH, & Robert M. Califf MD – Earlier, we discussed a pair of concepts – interoperability and connectivity – that are essential prerequisites for the creation of a successful national system for evidence generation. We take a look at how we would apply these constructs as we go about building such a system.
By Rachel E. Sherman MD, MPH, & Robert M. Califf MD – Across the clinical research enterprise, there is a growing awareness of serious shortfalls in the current paradigm of generating the scientific evidence that supports medical product evaluation and clinical care decisions and the need to modernize methods and expectations surrounding this evidence base.
By Douglas C. Throckmorton MD – In past years, we’ve collected more than 200 pounds of unused medications that would have otherwise lingered in medicine chests and kitchen cabinets. FDA’s event is in advance of National Drug Take Back Day, marked on April 30.
By Bakul Patel – As Yoda might say: build a case for interoperability, we must. While we may not have yet realized the technological accomplishments of Yoda’s advanced world, today connectivity shows great promise for the future. From blood pressure to brain scans, today’s health care allows for the rapid transfer and use of information between and among different medical devices.
By Jonca Bull MD – February is American Heart Month. Heart disease remains a significant problem in the United States – it’s the leading cause of death, disproportionately affecting minorities. In particular, minorities have higher rates of hypertension, diabetes, and smoking, which are risk factors that can cause heart disease.
By Robert M. Califf MD & Rachel Sherman MD, MPH – Medical care and biomedical research are in the midst of a data revolution. Networked systems, electronic health records, electronic insurance claims databases, social media, patient registries, and smartphones and other personal devices together comprise an immense new set of sources for data about health and healthcare.
By Howard Sklamberg, J.D., Jeffrey Shuren, M.D., J.D., & Melinda K. Plaisier, M.S.W. – Across FDA, we are devoting tremendous effort, in collaboration with a variety of stakeholders, toward activities that drive–and increase–product and manufacturing quality.
By Nina L. Hunter PhD & Robert M. Califf MD – We recently announced the first FDA Patient Engagement Advisory Committee (PEAC), supported by the Center of Devices and Radiological Health (CDRH). The Committee will provide advice to the FDA Commissioner on complex issues relating to medical devices, the regulation of devices, and their use by patients.