The below letter was directed to Medical Device Establishments in August 2017 to address FDA Medical Device User Fee Rates for Fiscal Year 2018 as follows: This letter provides information regarding medical device user fees, including fee rates and payment procedures, for fiscal year 2018 (FY18), which runs from October 1, 2017 through September 30, … Read more
January 01, 2019 Now the Chicago team has uncovered a key part of that process: a nonfunctioning, or “zombie” gene. The gene, called LIF6, is activated in elephants by p53, after which it kills cancer precursor cells. They believe that the discovery, which they described in the journal Cell Reports, could boost efforts to develop drugs for people … Read more
December 28, 2018 In comments released in August 2018, AdvaMed said it disagreed with FDA’s position on what should be considered valid economic factors to determining profit eligibility, while also taking issue with a lack of clarity that randomized controlled trials are not necessary to demonstrate probable benefit. “To demonstrate probable benefit, standard of care … Read more
December 26, 2018 Collins was a member of Innate’s board of directors and held a 17% stake in the biotech. According to prosecutors, Collins learned from Innate’s CEO trial had failed on June 22. Collins replied, “Wow. Makes no sense. How are these results even possible???” before calling his son, Cameron. Prosecutors think Collins told … Read more
December 20, 2018 The Agency (United States Food and Drug Administration/FDA) has more than doubled the number of press releases it sent out in the first half of 2018, with 126 press releases so far compared to 52 last year. However, the most notable increase has been in Commissioner Statements. FDA Commissioner Scott Gottlieb put … Read more
December 18, 2018 In collaboration with the Alzheimer’s Drug Discovery Foundation (ADDF), the new Diagnostics Accelerator will aim to back promising research that may not guarantee an immediate commercial return — hoping to take more risks than a traditional VC fund, while also focusing on products being developed for market, over basic science research. One … Read more
December 13, 2018 You may already know the major plot points that have come to light over the past few years; however, that does not make the book, Bad Blood: Secrets and Lies in a Silicon Valley Startup, any less enjoyable. And that is credit to the engrossing writing and reporting from the Wall Street … Read more
December 11, 2018 The Agency approved Epidiolex, or purified cannabidiol, to treat Lennox-Gastaut syndrome and Dravet syndrome in patients 2 and older. The conditions typically begin in childhood, with frequent or prolonged seizures, and patients have a high risk of death from seizure-related causes and infections. Though other drugs are approved to treat Lennox-Gastaut syndrome, Epidiolex … Read more
December 06, 2018 “We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria,” FDA Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said in November. … Read more
December 04, 2018 The series of stories published in November 2018 across several outlets details the patchwork of international regulatory regimes overseeing the medical device industry, finding products being marketed with little to no human testing, or devices pulled from sale due to safety concerns in some countries while still being sold in others. For … Read more