Regulatory and Compliance
Feb 26, 2015
Marie Thibault A bill intended to protect FDA user fees from sequestration was reintroduced Wednesday in the U.S. House of Representatives. This legislation...
Feb 25, 2015
Marie Thibault In a final order to be published Thursday, FDA is confirming that the Assisted Reproduction Embryo Image Assessment System is now classified...
Feb 24, 2015
Marie Thibault In a final order published Tuesday, FDA has reiterated that powered exoskeletons, like those made by Ekso Bionics and ReWalk Robotics, will be...
Feb 23, 2015
Marie Thibault In response to FDA’s call for better postmarket surveillance, a new report has outlined a plan to create the National Medical Device...
Feb 20, 2015
Arundhati Parmar After slapping consumer genetic testing company 23andMe for marketing a test to consumers without regulatory clearance, FDA is essentially...
Feb 19, 2015
Jamie Hartford Robert Califf A Duke University cardiologist whose name has been floated as a possible successor to exiting FDA commissioner Margaret...
Feb 18, 2015
The most common pathway to market for medical devices is coming under fire from a social media campaign led by activists determined to get FDA to ban power...
Feb 13, 2015
The agency recently denied three petitions seeking to ban mercury-based dental amalgams, which some studies have linked to kidney damage and neurological...
Feb 06, 2015
Shana Leonard Dennett Kouri Increased regulatory oversight in the past year or two has forced quality, regulatory, and compliance personnel to be on...
Feb 06, 2015
  Steve Schultz and Doretta Slater The FDA inspection process is a cornerstone of the agency's mission of ensuring safety and efficacy in medical products...