Please join MassDevice and J29 Associates for an Executive Roundtable Breakfast & Focus Session Finding the cause of thrombosis in some immunoglobulin treatmentsBy: Mikhail Ovanesov, Ph.D. The Food and Drug Administration’s Office of Blood Research and Review (OBRR) has a broad mission to ensure the safety and efficacy of products it regulates. It also does mission-related research, some of which can be described as problem-solving. Digital disease detection: We see the trends, but who is actually sick?Filling information gaps for women in medical device clinical trialsBy David Strauss, M.D., Ph.D. At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices—devices, such as implantable heart devices, that carry the greatest risk to patients and have the potential to save or sustain life. US FDA outlines plans for device review process improvementsBy Stewart Eisenhart, Emergo Group FDA encourages medical device data system innovationBy: Bakul Patel Thanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health. Malaysian medical device market regulators clarify, expand policiesBy Stewart Eisenhart, Emergo Group Medical device market regulators in Malaysia have implemented several new policiespertaining to the country’s recently enacted Medical Device Act. FDA leverages big data via cloud computingBy: Taha A. Kass-Hout, M.D., M.S. Last year, I worked with a group of colleagues throughout the Food and Drug Administration (FDA) on a project that is critical for the agency’s future: the modernization of our information technology platforms to prepare for the influx of "Big Data" – the enormous data sets we receive daily from manufacturers, health care providers, regulatory bodies, scientists and others. Adventures in gene therapy: Getting our own blood vessels to make drugsAnticipating autism through functional neuroimagingIs 9-month-old Mila Goshgarian at risk for developing autism spectrum disorder (ASD)? Her 4-year-old twin brothers are both on the spectrum, so statistically her chances are at least 20 percent. FDA issues draft guidances for industry on social media and internet communications about medical products: Designed with patients in mindBy: Thomas Abrams |