Latest From Elizabeth Orr
Investors in surgical robotics company Auris say Johnson & Johnson failed to support the company per their merger agreement.
COVID-19: Newly Authorized Device From OraSure Subsidiary Allows At-Home Collection Of Saliva Samples
The device is among the first that does not require a health care professional to supervise the saliva sample-collection process.
The document recommends testing for blood biotin levels as high as 3500 ng/mL, three times the maximum expected clinical concentration.
The US Department of Justice says the company provided advertising assistance and educational grants to health care providers that used its embolization devices.
The US FDA hopes to finalize or issue draft guidance documents on about 30 topics in fiscal year 2021.
On this week’s podcast: The US FDA was busy with draft and final guidance documents this week, issuing three within 24 hours. The docs address disparate device industry concerns, ranging from of-the-moment issues like coronavirus test supplies, to more traditional concerns around device materials testing.