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April 3, 2020: FDA Issues Update on COVID-19 (Coronavirus) Response

FDA COVID-19 Update News – On April 3, 2020, the U.S. Food and Drug Administration (FDA) issued an announcement with their continuing COVID-19 response.

FDA COVID-19 Update Information

The FDA has announced the following updates:

  1. They are working in collaboration with government, industry, and academic partners to develop and implement a protocol to provide convalescent plasma to patients in need throughout the U.S. Convalescent plasma, or plasma from people who have had the virus, has the potential to lessen the severity or shorten the length of illness from COVID-19.
  2. An FAQ as to whether respirators approved under standards used in other countries, such as KN95s, can be used in the US during the COVID-19 pandemic has been posted. A new Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China has been issued allowing use of respirators approved in other countries, under certain criteria. The FDA is also issued revised guidance to aid in expanding the availability of general use face masks for the general public and respirators for health care professionals during the COVID-19 pandemic.
  3. Guidance has been issued as to how studies with new and ongoing animal drug development should be conducted. These recommendations have been issued for the safety of animals, their owners, study personnel, and to be able to maintain compliance with good laboratory practice regulations and good clinical practices, as well as to maintain the scientific integrity of the data during the COVID-19 pandemic. The guidance is in alignment with recommendations for sponsors of human drugs, biologics, and medical devices previously released in March.
  4. Importers will be requested to produce records under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) rule electronically (or via other prompt methods) to the FDA as they pivot to conducting such inspections remotely during the ongoing pandemic.
  5. Another extension as to the comment period for the Laboratory Accreditation for Analyses of Foods proposed rule has been given for ninety (90) additional days. This period had previously been extending until April 6, 2020. Due to the ongoing COVID-19 public health emergency, the new deadline for the comment period will be July 6, 2020.
  6. A guidance document has been released regarding the FDA’s temporary policy regarding packaging and labeling of shell eggs sold by retail food stores during the COVID-19 pandemic to provide temporary flexibility as to the packaging and labeling of shell eggs sold to consumers.

Per the FDA, they have issued the following diagnostics updates:

During the COVID-19 pandemic, the FDA has worked with more than 240 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.

To date, 28 emergency use authorizations have been issued for diagnostic tests.

The FDA has been notified that more than 125 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.

The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

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