March 05, 2019 Members of the Subcommittee on Agriculture, Rural Development, FDA and related agencies questioned Gottlieb on the status of the Agency’s operations, particularly regarding efforts to mitigate the impact of the government shutdown. T hey pointed to FDA’s inspectional work of medical product manufacturing facilities and reserve of industry user fees as areas … Read more
March 01, 2019 What’s different about the FDA’s latest untitled letter? It involves words spoken by a sales rep. It marks only the 14th time a Warning or Untitled Letter has involved an oral statement, said Mark Senak, a Public Relations professional and Eye on FDA blogger. The last time a sales rep was involved … Read more
February 26, 2019 The discovery, reported in the journals Nature Communications and eLife, is a code that is found in both large and small ribonucleic acids (RNAs). The researchers also have early evidence that the small RNAs, called microRNAs, can be introduced into cells to trigger the kill switch. “My goal was not to come … Read more
February 21, 2019 By using optical coherence tomography angiography, or OCT scans, researchers observed cross sections of patients’ retinas, visualizing the changes seen in its smallest blood vessels. They believe that the deterioration of the retina may mirror the disease’s progression in the brain, conveyed across the optic nerve. The researchers were able to detect … Read more
February 19, 2019 The session at a conference jointly hosted by the American University Washington College of Law and the Food and Drug Law Institute in October featured former FDA commissioners Robert Califf, Margaret Hamburg, David Kessler and Andrew von Eschenbach. Lewis Grossman, Professor of Law at the American University, questioned the former commissioners on … Read more
February 15, 2019 Her interest was initially piqued by a Harvard study that found older patients who had female doctors had better outcomes than those with male doctors. That got Dorfman thinking about what, if anything, that might mean for CMI/Compas clients who want to contact, converse with and educate physicians about their products. The upshot: Should pharma companies … Read more
February 12, 2019 Rather than using human neurons, the Tufts team used human-induced pluripotent stem cells (iPSCs) to build their models. The resulting models carried the key structural and functional features of the brain and maintained neural activity for at least nine months, the team reported in the journal ACS Biometerials Science & Engineering. Because … Read more
February 07, 2019 Much speculation has surrounded when and how the tech giant would jump into the healthcare waters — and it did so with a large splash, unveiling the new Series 4 model and its federal de novo clearance at Apple’s iPhone launch event in Cupertino, California. Additionally, through new accelerometer and gyroscope hardware, … Read more
February 06, 2019 The Health and Human Service (HHS) Inspector General’s Office recommended the FDA and manufacturers use pre-submission meetings to better address cybersecurity-related questions, and that the agency include cybersecurity as an element in its SMART template used in 510(k) submissions. In addition, the Office urged the agency to begin requiring cybersecurity documentation elements … Read more
January 31, 2019 The EMA is set to leave its offices in London 01 MAR 2019 and start gradually moving staff into its temporary home in Amsterdam about 10 days later. In the intervening week, the EMA will “operate on the basis of extended teleworking,” with only a small number of staff occupying its Amsterdam … Read more