Coronavirus (COVID-19) Update: December 21, 2021

FDA News Release

• For Immediate Release: December 21, 2021

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

• On December 20, the FDA’s Center for Veterinary Medicine (CVM) announced an eSubmitter update that will enable animal drug manufacturers to provide more complete facility information, particularly about the establishments that are actively used in their manufacturing processes. Collecting facility information will enable CVM to rapidly access supply chain data and information on animal drug products, active pharmaceutical ingredients, and the status of manufacturing sites, so that the Agency can identify supply chain issues, as well as critical facilities and animal drugs impacted by emerging diseases or natural disasters. The enhancement will also help CVM to address potential animal drug supply chain issues and identify solutions to potential animal drug shortages. The enhancement is part of the Animal Drug and Manufacturing System (ADMS), a project funded by The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) in response to the COVID-19 public health emergency.
• In a new project funded by the FDA, Australia’s national science agency CSIRO (Commonwealth Scientific and Industrial Research Organisation) and its global partners will use systems biology and machine learning approaches to enhance the understanding of nonclinical model responses to SARS-CoV-2. This project aims to develop the underpinning regulatory science needed to help the FDA evaluate nonclinical model data for assessing potential vaccines and therapeutics for COVID-19, including the impact of omicron, and future SARS-CoV-2 variants of concern.
• Testing updates:
  • As of today, 418 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 290 molecular tests and sample collection devices, 87 antibody and other immune response tests and 41 antigen tests. There are 67 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
  • The FDA has authorized 22 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 738 revisions to EUA authorizations.