Emergency Use Authorization (EUA) updates

Emergency Use Authorization (EUA) updates

FDA broadens EUA for Veklury (remdesivir) to include all hospitalized patients for treatment of COVID-19 FDA broadened the scope of the existing EUA (PDF) for the drug Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease. In May 2020, the FDA issued an EUA that authorized Veklury for the treatment of hospitalized adult and pediatric patients with severe COVID-19. As noted in the initial issuance of the EUA, the emergency use of Veklury was limited to those patients with severe disease, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator. On August 28, 2020, based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients. The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses. (August 28, 2020)

FDA authorizes first diagnostic test where results can be read directly from testing card FDA issued an EUA (PDF) for the first antigen test where results can be read directly from the testing card, a similar design to some pregnancy tests. This simple design is fast and efficient for healthcare providers and patients and does not need the use of an analyzer. (August 26, 2020)   Diagnostic test EUAs To date, FDA has currently authorized 235 tests under EUAs, which include 190 molecular tests, 41 antibody tests, and 4 antigen tests. Also see: Coronavirus Testing Basics

Related links: FAQs on Testing for SARS-CoV-2 (frequently updated) Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices