Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:
On July 24th, the FDA reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 Coronavirus symptoms or who have no reason to suspect COVID-19 Coronavirus infection, and to allow pooled sample testing.
Specifically, the FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to expand use of the test to anyone after the company provided scientific data showing the test’s ability to detect SARS-CoV-2 in a general, asymptomatic population.
Additionally, the reissuance also includes authorization for LabCorp to test pooled samples containing up to five individual swab specimens collected under observation. In general, sample pooling allows for fewer tests to be conducted overall, conserving resources and potentially allowing more tests to be evaluated more quickly.
The agency issued a warning earlier this month about an increasing number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death, primarily reported to poison control centers and state departments of health. The agency continues to see these figures rise.
- The agency has also taken additional action to help prevent certain hand sanitizers from entering the United States by placing them on an import alert. The FDA is proactively working with manufacturers to recall products and is encouraging retailers to remove products from store shelves and online marketplaces. A warning letter has also been issued to Eskbiochem S.A. de C.V. regarding the distribution of products labeled as manufactured at its facilities with undeclared methanol, misleading claims — including incorrectly stating that FDA approved these products — and improper manufacturing practices.
On July 24th, the agency approved an abbreviated new drug application, or generic, for heparin sodium. The FDA continues to work to help patients suffering from COVID-19 Coronavirus by reviewing and approving generic medicines, such as anti-coagulants, used in the prevention and treatment of blood clotting.
On July 24th, FDA issued emergency use authorizations (EUAs) to two companies for serology-based tests for the qualitative detection and differentiation of IgG and IgM antibodies to SARS-CoV-2. The tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
The companies that were each issued an EUA are:
- Xiamen Biotime Biotechnology Co., Ltd., for its BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test, and
- Access Bio, Inc., for its CareStart COVID-19 IgM/IgG.
To date, the FDA has currently authorized 191 tests under EUAs; these include 156 molecular tests, 33 antibody tests, and 2 antigen tests.
About the U.S. Food and Drug Administration
The U.S. Food and Drug Administration (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.