FDA COVID-19 Update

contractpharmaApril 28, 2020

Tag: FDA , COVID-19 , hydroxychloroquine , Chloroquine

The U.S. FDA has taken the following actions as of Aril 24 in its ongoing response effort to the COVID-19 pandemic:

The FDA issued an immediately in effect guidance, Enforcement Policy for Remote Digital Pathology Devices During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency, to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides during this public health emergency.

The FDA issued a Drug Safety Communication regarding known side effects of hydroxychloroquine and chloroquine, including serious and potentially life-threatening heart rhythm problems, that have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. These risks, which are in the drug labels for their approved uses, may be mitigated when health care professionals closely screen and supervise these patients such as in a hospital setting or a clinical trial, as indicated in the Emergency Use Authorization (EUA) for these drugs to treat COVID-19. 

The FDA and Federal Trade Commission issued a warning letter to a seller of fraudulent COVID-19 products, as part of the agency's effort to protect consumers. The seller warned, Prefense LLC, offers unapproved and misbranded hand sanitizer products for sale in the U.S. with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.

Diagnostics update to date: 

  • During the COVID-19 pandemic, the FDA has worked with more than 380 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. 
  • To date, the FDA has issued 44 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 19 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs). 
  • The FDA has been notified that more than 225 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. 

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