On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely...more
Last week, the U.S. Food and Drug Administration (FDA) took yet another step to encourage production of basic medical supplies in the battle against COVID-19. On Friday, March 20, FDA published two new guidance documents...more