On Jan. 27, BioFire Defense’s COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal. In fact, almost all of the more...
They’re baaaack! FDA surveillance inspectors returned to the beat on Monday, at least for domestic operations. On Dec. 31, the agency announced a temporary freeze on all but “mission-critical” inspections to protect inspectors from Omicron. The freeze, the second...