September 10, 2020 The patient was first diagnosed with coronavirus in April 2020 after he had a sore throat, cough, headache, nausea and diarrhea, the researchers wrote in a pre-print study posted at the end of August. He got better around April 27, and he tested negative for the virus twice afterwards. He continued to … Read more
September 08, 2020 While this may serve as little comfort, hospitals in regions getting hit by the new wave of the deadly virus do have the benefit of seeing how hospitals in the Upper Midwest and the Northeast managed the pandemic. One of the easiest — or at least most evident — lessons available is … Read more
September 03, 2020 The Centers for Medicare & Medicare Services (CMS) released an emergency regulation on 25 AUG 2020 calling for the mandatory reporting. The Agency also posted new requirements for lab reporting and revised a policy for physician and pharmacist orders for COVID-19 tests. “While many hospitals are voluntarily reporting this information now, not … Read more
September 01, 2020 For a vaccine that would be widely deployed against COVID-19, FDA says it expects sponsors to demonstrate that the vaccine is at least 50% effective in a placebo-controlled trial. At a Senate Health, Education, Labor and Pensions committee hearing on 30 JUN 2020, FDA Commissioner Stephen Hahn, MD, testified that FDA would … Read more
August 27, 2020 The study focused on 57 COVID-19 patients who needed a ventilator to breathe. Researchers compared samples of their blood to that from patients who did not need a ventilator. They found that blood levels of a certain cytokine are predictive of the course of COVID-19. Cytokines are proteins that are central to … Read more
August 25, 2020 As a safety measure, FDA will pre-announce all inspections, except for retail tobacco inspections, for the foreseeable future. The announcement comes nearly two (2) months after the Agency said it will implement a phased approach to restarting surveillance inspections and four (4) months after the agency halted its domestic inspection program. However, … Read more
August 20, 2020 The observational study of Abbott’s FreeStyle Libre system, presented at the annual scientific sessions of the American Diabetes Association (ADA), pointed to an 0.8 percentage-point drop — from 8.5% to 7.7% — in overall A1c levels after six months of use. After one year, that drop came to 0.6 percentage points. According … Read more
August 18, 2020 Some contain flimsy surgical masks or cloth face coverings that are explicitly not intended for medical use. Others are missing items or have far less than the full weeks’ worth of protective equipment the government promised to send. Instead of proper medical gowns, many packages hold large blue plastic ponchos. “It’s like … Read more
August 11, 2020 The move is similar to a previous Agency authorization issued in late March that broadly covered ventilators and respiratory devices, in a bid to quickly expand their supply against the pandemic. That policy allowed alternative or modified devices to be used for ventilation, such as anesthesia gas machines, as long as they … Read more
August 06, 2020 But instead of testing one product, the Fitbit Heart Study plans to use several — including all of its current exercise trackers and smartwatches that can measure heart rate — to potentially enroll hundreds of thousands of people. The trial’s results will serve as the foundation for the company’s regulatory submissions to … Read more