- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA issued a statement that it is actively working with our federal partners, international regulators and medical product companies to quickly address any potential impacts of the new omicron variant on the tools to fight the pandemic. The agency is working as quickly as possible to evaluate the potential impact of this variant on the currently available diagnostics, therapeutics and vaccines. The FDA is closely monitoring the situation and is committed to communicating with the public as it learns more.
- In a new project funded by the FDA, Embleema and George Washington University will conduct bioinformatic research and system development to expand the FDA-ARGOS database. FDA-ARGOS contains curated, quality-controlled 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. Building on expansions during the COVID-19 pandemic, this project aims to further improve the utility of the FDA-ARGOS database as a key tool for medical countermeasure development and validation.
- Testing updates:
- As of today, 423 tests and sample collection devices are authorized by the FDA under emergency use authorizations (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 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 20 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 696 revisions to test EUA authorizations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Kim DiFonzo