Lori A Carr October 11, 2018 SIU professor William Halford, who died in June, injected participants with his experimental herpes vaccine in St. Kitts and Nevis in 2016 and in Illinois hotel rooms in 2013 without safety oversight that is routinely performed by the FDA or an Institutional Review Board (IRB). According to four people with knowledge about … Read more
October 09, 2018 Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye. Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause … Read more
October 04, 2018 The action could have negative consequences for medical device manufacturers and the patients who use their products. Chinese-made products account for a significant minority of devices imported into the U.S. Some of the imported devices come from Chinese companies. Others are manufactured by Western companies with operations in China. Estimates of the … Read more
October 02, 2018 Woonsocket, Rhode Island-based CVS established itself as a national brand through its pharmacies; however, over the past decade or so it has broadened its scope, notably by merging with pharmacy benefit manager (PBM) Caremark Rx and striking a deal to buy insurer Aetna. Now, CVS is moving onto turf traditionally colonized by … Read more
September 27, 2018 The Regulatory Agency (CDSCO) told the Economic Times it is in the process of finalizing the software to be used for the database and will amend its rules and regulations to make it mandatory for manufacturers to regularly put details of their facilities and products into the database. India does not have … Read more
September 25, 2018 The package (Chinese) would allow certain qualified generics makers to be designated as high-tech enterprises, a label that comes with a 15% corporate tax rate, compared to 25% for other companies. The policy also makes clear that China considers compulsory patent licensing a bona fide option during public health emergencies or shortages of … Read more
September 20, 2018 Now patients of 39 health systems covering hundreds of hospitals and clinics can view their Electronic Health Records (EHR) from all participating institutions aggregated together on their iPhone. It means patients and physicians can better view medical information in the healthcare setting; however, it could also change the clinical trial landscape, according … Read more
September 18, 2018 A team of scientists led by the University of Southern California’s Roski Eye Institute built a retinal implant from embryonic stem cells, and they have early but encouraging evidence from a small clinical trial that it may improve visual functioning in people with advanced dry AMD. The implant is designed to mimic … Read more
September 13, 2018 The FDA is advising consumers to discard the products that are part of the mandatory recall, which include, but are not limited to: Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red. The FDA understands that … Read more
September 11, 2018 Local companies gained preference over foreign businesses under Indian public procurement rules last year. But those general, pan-industry rules stopped short of stipulating how the “Make in India” promotional agenda would apply to the procurement of medical devices. A draft document released by the Department of Pharmaceuticals (DoP) has now filled that … Read more