HHS is withdrawing a 2020 policy that limited the FDA’s review process of certain lab tests, including some COVID-19 tests, the agency said Nov. 15. The policy was originally put in place to help labs ...
SAN FRANCISCO (KGO) -- It's the next frontier of COVID-19 testing - looking for antibodies to the virus. ABC7 news got an inside look at the San Francisco lab that is validating a coronavirus antibody ...
A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed ...
The Food and Drug Administration announced a controversial final rule aimed at improving the safety of laboratory diagnostic tests following years of controversy about the agency’s oversight of the ...
A single oral antiviral that works against common colds, influenza, COVID-19, and other respiratory infections sounds like ...
Researchers at the University of Pennsylvania School of Medicine have developed a diagnostic test for COVID-19 made of scalable materials that can deliver results within minutes at a fraction of the ...