Lori A Carr May 22, 2018 The MDSAP consortium announced Oct. 31, 2017 it has tweaked the program, in response to comments received from Canadian medical device license holders, by the actions as follows: reducing the total number of tasks; introducing reduction in audit time for manufacturers; reducing the duration of surveillance and re-certification audits; and clarifying the … Read more
May 17, 2018 FDA Commissioner Scott Gottlieb, M.D., is proposing to grant these freedoms to companies that complete a one-time review. In shifting regulatory attention from individual products and onto the companies that make them, the FDA is following the playbook it created for digital health. Both of the approaches loosen regulatory oversight of pre-certified … Read more
May 16, 2018 A new policy from the Senate’s National Defense Authorization Act, which is going through committee, would allow the Pentagon to approve devices and drugs not green-lit by FDA to be used on military personnel “for emergency use.” The plans were first published in November 2017 by Politico. However, Gottlieb (FDA Commissioner) has … Read more
May 10, 2018 As someone who enjoys eating out with my family and picking up the occasional take-out meal, I – like many Americans – want to know what’s in the food I eat. As FDA Commissioner, I also know that more people are eating meals away from home, and our diets are increasingly comprised … Read more
May 08, 2018 Direct-to-consumer (DTC) access to GHR tests is made possible by advances in technology. With a small saliva sample, consumers can retrieve their genetic risk result directly from the test provider’s website. As consumer interest in genetic risk information grows, opportunities are also expanding for the detection of additional genetic conditions and diseases … Read more
May 03, 2018 In a phase 2 trial involving 63 children, Joanne Kurtzberg and her team gave patients an infusion of their own cord blood that had been banked at birth. The doses ranged from 10 million stem cells per kilogram of body weight to 50 million per kilogram. A year later, they found that … Read more
May 01, 2018 According to results published in the British Medical Journal, 57% of indications approved during that period hit the market based on endpoints other than overall survival or improved quality of life. Instead, they won their green lights via “surrogate” endpoints such as tumor shrinkage or progression-free survival. And after a median of five years … Read more
April 26, 2018 Hippo signaling can prevent damaged heart muscle from repairing itself. So the Baylor researchers wanted to see what would happen if they turned off the pathway altogether. When they silenced Hippo for 6 weeks in mouse models of heart failure, they were able to restore pumping ability to that of healthy hearts, according to … Read more
April 24, 2018 And unlike that tattoo you got on a wild night in college, you are not stuck with it. With enough refinement, the scientists expect to make tattoos that only last for as long as you need them. They could be invisible unless subjected to certain kinds of light, too, so you would … Read more
April 19, 2018 A team of scientists at Yale, the University of Tennessee Health Science Center and the University of Bonn zeroed in on macrophages, immune cells that are primarily engaged in fighting infections. They discovered a new type of macrophage in the nerves that are inside belly fat. As these macrophages age, they become inflamed, … Read more