April 8, 2020

FDA issues COVID-19 update

By: Judy Mathias

Editor's Note

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.

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