emergency use authorization
In Brief This Week: Labcorp, Thermo Fisher Scientific, Lucence, Foresight Diagnostics, More
News items for the week of Feb. 24, 2025.
FDA Publishes Draft Guidance on Test Validation, Submission for EUAs
FDA officials said that the draft guidance is meant to address recommendations from two reports on the agency's response to COVID-19.
Healgen Gains FDA Marketing Authorization for OTC COVID, Flu A/B Test
The firm received de novo marketing authorization for its combination antigen test, and the developers of subsequent tests will be able to seek 510(k) clearance.
Acon Laboratories Gets FDA Emergency Use Authorization for OTC COVID, Flu Test
The EUA marks the latest in a series of authorizations that San Diego-based Acon has received for its COVID-19 tests in recent months.
FDA Grants Emergency Use Authorization for Nano-Ditech's Flu/COVID Point-of-Care Test
The New Jersey- based company, which is a subsidiary of South Korea's Precision Biosensor, recently received Emergency Use Authorization for an over-the-counter COVID test.