FDA COVID-19 Update

03.25.20

Daily roundup for March 25, 2020.

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

  • The FDA is facilitating access to convalescent plasma, antibody-rich blood products taken from blood donated by people who have recovered from the COVID-19 virus, that could shorten the length, or lessen the severity, of the illness. The agency will be using multiple pathways to support these efforts and has posted information for investigators wishing to study convalescent plasma in patients with serious or immediately life-threatening COVID-19 infections.
  • In response to continued filtering facepiece respirator (FFR or respirator) shortages, FDA has concluded that certain imported disposable FFRs that are not NIOSH-approved are appropriate to protect the public health or safety. Under this EUA, authorized respirators listed in the letter are authorized for use in healthcare settings when used in accordance with CDC recommendations.
  • The FDA issued a Consumer Update advising consumers to be beware of fraudulent coronavirus tests, vaccines and treatments. For example, the FDA is aware of people trying to prevent COVID-19 by taking a product called chloroquine phosphate, which is sold to treat parasites in aquarium fish. The agency warns not to take any form of chloroquine unless it has been prescribed by a health care provider and obtained from legitimate sources.
  • Diagnostics update: In certain emergencies, the FDA can often quickly issue an emergency use authorization for diagnostic tests based on FDA's rolling review of data and where the request meets certain criteria. To date, 16 emergency use authorizations have been issued for nation-wide use, including one today. Under our laboratory developed test policy during COVID-19, the FDA has been notified by more than 65 laboratories.
  • The FDA took action to increase U.S. supplies to support the U.S. response to COVID-19 by providing instructions to manufacturers importing personal protective equipment and other devices. The agency is engaging with importers and others involved in the import trade community during this pandemic to facilitate the entry of needed products, including PPE, into the U.S. These instructions to importers clarify the types of PPE that can be imported without engaging with FDA.