Lori A Carr April 02, 2019 The de novo clearance makes it the first hearing aid authorized by the Agency that allows users to fit, program and control the device on their own, without help from a healthcare provider. The Bose Hearing Aid is a wireless amplifier placed in the ear canal that can be adjusted by the … Read more
March 28, 2019 Already since the midterms, Democratic lawmakers have floated a bill directing the Department of Health and Human Services (DHHS) Secretary to break patents and allow generic competition when U.S. branded drug prices come in above their median price in Canada, the U.K., Germany, France and Japan. Additionally, Sen. Elizabeth Warren and Rep. … Read more
March 26, 2019 Sound familiar? Trial lawyer “bad drug” ads have proliferated for years; however, one newly formed organization is pushing back. The Partnership to Protect Patient Health is a coalition of national physician and patient advocacy groups that believe the lawsuit advertising needs to be addressed as a healthcare issue that can disrupt physician-patient relationships. … Read more
March 21, 2019 The watch can now also track a person’s pulse in the background and send the wearer a notification if it detects what could be atrial fibrillation, the most common form of irregular heart rhythm. The notification feature will also work with heartbeat sensors on earlier versions of the Apple Watch, alerting the … Read more
March 19, 2019 Sharpless, who has served as NCI director since October 2017, previously served as Director of the University of North Carolina (UNC) Lineberger Comprehensive Cancer Center, a position he held since January 2014. He earned his medical degree from the UNC School of Medicine, completed his internal medicine residency at the Massachusetts General … Read more
March 14, 2019 The plan is allocating $35.4 billion for the NIH — estimated to be somewhere between $4.5 and $6 billion less than in the current financial year — and is accompanied by other cuts including a $1 billion reduction for the National Science Foundation (NSF). Among the biggest losers within the NIH are … Read more
March 12, 2019 Gottlieb was biopharma-friendly — to the point where the Nasdaq biotech index plummeted at the news of his departure; however, he also made a few moves companies did not particularly like. Speeding up generics, for instance, and decrying the games branded drugmakers play to keep copycats from hitting the market. Now, he … Read more
March 07, 2019 Gottlieb won Senate confirmation as FDA Commissioner back in May 2017, an uncertain time for the drug industry. During the selection process, his name had been favored by a majority of biopharma executives polled by an analyst. At the time, one anonymous executive said he is the “least likely to rail for the … Read more
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