- For immediate release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response to the COVID-19 pandemic:
- Today, the FDA issued a statement that it is actively working with our federal partners, international regulators and medical device companies to rapidly address potential impacts of the new ommicron variant on the tools to fight the pandemic. The agency is working as soon as possible to evaluate the potential impact of this variant on currently available diagnostics, therapies and vaccines. The FDA is closely monitoring the situation and aims to communicate with the public as it learns more.
- In a new project funded by the FDA, Embleema and George Washington University will conduct bioinformatics research and systems development to expand the FDA-ARGOS database. FDA-ARGOS contains composite, quality-verified genomic sequence data to support research and regulatory decisions. For example, researchers can use the FDA-ARGOS along with bioinformatics tools to validate the performance, sensitivity, and specificity of diagnostic tests with computer modeling. This project builds on expansions during the COVID-19 pandemic and aims to further improve the usability of the FDA-ARGOS database as an important tool for the development and validation of medical countermeasures.
- Testing updates:
- As of today, 423 tests and sample collection devices have been approved by the FDA under Emergency Approvals (EUAs). These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests, and 40 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with self-collected samples. There is one EUA for a home molecular prescription test, three EUA for a prescription home antigen testing, 11 EUA for an over-the-counter (OTC) antigen self-test, and three EUA for OTC home molecular testing.
- The FDA has approved 20 antigen tests and nine molecular tests for serial screening programs. The FDA has also approved 696 revisions to test EUA authorizations.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.