January 15, 2019 Gottlieb and his colleagues have spent the past few weeks juggling their resources to cope with the furloughing of around two-fifths (2/5) of the FDA’s staff and loss of the ability to receive new user fees. Most recently, senior leaders at the FDA have worked with public health experts to identify additional … Read more
January 11, 2019 The marketing authorization is the second for Brainsway’s deep transcranial magnetic stimulation (TMS) device in the U.S., after being cleared for treatment-resistant major depressive disorder in 2013. The Jerusalem-based company intends to begin installing the OCD treatment in clinics immediately, as an upgrade to its current systems as well as through new … Read more
January 08, 2019 Each of those officials from the old China FDA (CFDA), recently revamped as the State Drug Administration, has been handed different penalties, according to the state-run China Central Television (in Chinese). The crackdown stems from an investigation of Changchun Changsheng Life Sciences, which recently turned up evidence that it had sold nearly … Read more
January 03, 2019 While TV ads still rule with a 65% recall among patients who saw any prescription drug ads in the past year, digital is rising with 49% remembering online ads, according to DRG Digital/Manhattan Research’s annual Cybercitizen Health study in the U.S. Another 25% of patients reported seeing ads in print, 14% remembered … Read more
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