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FDA COVID-19 Update

EUAs, Clinical Trial guidance updates, and Diagnostics update

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By: Kristin Brooks

Managing Editor, Contract Pharma

The following are some of the U.S. FDA’s actions taken, as of March 31, in its ongoing response effort to the COVID-19 pandemic:

  • On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19.
  • On March 29, 2020, the FDA issued an immediately in effect guidance that outlines an enforcement policy to help expand the availability and capability of sterilizers, disinfectant devices and air purifiers.
  • The FDA amended the Emergency Use Authorization (EUA) for the Battelle Decontamination System for use in decontaminating compatible N95 respirators for reuse by health care personnel during the COVID-19 pandemic, allowing for these devices, when decontaminated, to be reused.
  • The FDA issued an updated guidance, “Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,” with an appendix adding questions and answers on this subject. This guidance is intended for industry, investigators and institutional review boards and was issued because we recognize that the COVID-19 pandemic may impact the conduct of clinical trials of medical products, including drugs, devices and biological products.
  • Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 230 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 20 emergency use authorizations have been issued for diagnostic tests, including Abbott Diagnostics Scarborough, Inc., ID NOW COVID-19, a rapid (13 minutes or less) test.

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