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

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



For immediate release:

The United States Food and Drug Administration today announced the following actions taken as part of its ongoing response efforts to the COVID-19 pandemic:

  • On December 20, the FDA’s Center for Veterinary Medicine (CVM) announced an eSubmitter update that will allow manufacturers of animal drugs to provide more comprehensive information about facilities, especially facilities that are actively used in their manufacturing processes. Gathering facility information will allow CVM to quickly access supply chain data and information on animal pharmaceuticals, active pharmaceutical ingredients and the condition of manufacturing sites, so that the Agency can identify supply chain issues, as well as critical facilities and animal medicines affected by emerging diseases or natural disasters. The improvement will also help the CVM to address potential animal medicine supply chain issues and identify solutions to potential animal medicine shortages. The improvement is part of the Animal Drug and Drug Manufacturing System (ADMS), a project funded by the Coronavirus Relief, Relief and Economic Security Act (CARES Act) in response to the COVID-19 public health emergency.
  • In a new FDA-funded project, Australian national science agency Commonwealth Scientific and Industrial Research Organization (CSIRO) and its global partners will use systems biology and machine learning approaches to improve understanding of non-clinical model responses SARS-CoV-2. This project aims to develop the underlying regulatory science needed to help the FDA assess data from non-clinical models to assess vaccines and potential therapies for COVID-19, including the impact of omicron and future variants. of concern from SARS-CoV-2.
  • Testing updates:
    • To date, 418 tests and specimen collection devices have been approved by the FDA under Emergency Use Authorizations (EUA). These include 290 molecular tests and specimen collection devices, 87 antibody tests and other immune response tests, and 41 antigen tests. There are 67 molecular clearances and one antibody clearance that can be used with home samples. There is one EUA for home molecular prescription testing, three EUAs for home antigen prescription testing, 11 EUAs for over-the-counter (OTC) home antigen testing, and three EUAs for OTC molecular testing. home.
    • The FDA has authorized 22 antigen tests and nine molecular tests for serial screening programs. The FDA has also cleared 738 reviews of EUA approvals.

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The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.