Search for: "JEFFREY E. SHUREN" Results 1 - 11 of 11
Sorted by Relevance | Sort by Date
RSS Subscribe: 20 results | 100 results
24 Feb 2011, 1:59 am
Jeffrey Shuren, J.D., director of FDA's Center for Devices and Radiological Health, in the agency's news release.Although the R-Biopharm AG website says the test is reliable for sporadic cases as well as outbreaks, the FDA said it is not sensitive enough to diagnose individual patients, and should not be used when only one person has symptoms.To gain approval, the manufacturer demonstrated that the Ridascreen test could detect norovirus across stool samples about 2/3 of… [read post]
16 Feb 2011, 3:00 am by Bob Kraft
Jeffrey Shuren, the FDA's new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer. [read post]
16 Feb 2011, 2:56 am by Bob Kraft
Jeffrey Shuren, the FDA’s new device chief, has announced changes to strengthen the 510(k) process, and the Institute of Medicine will weigh in with the findings of its own review this summer. [read post]
18 Mar 2021, 9:03 pm by Max Masuda-Farkas
In the announcement, FDA officials Jeffrey E. [read post]