The Food & Drug Administration (FDA) on April 7 issued an update on actions the agency has taken in its ongoing response to the COVID-19 pandemic. The actions include:
a guidance for remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19
a guidance for extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass devices to help expand the availability of devices used in ECMO therapy
approval of an Abbreviated New Drug Application (ANDA) for Hydroxychloroquine Sulfate Tablets USP, 200 mg, for the treatment of malaria, lupus, and rheumatoid arthritis.
a diagnostics update noting that the FDA has worked with more than 270 test developers who will be submitting emergency use authorization (EUA) requests for tests that detect the coronavirus; to date 30 EUAs have been issued for diagnostic tests, and more than 150 laboratories have begun testing.