Coronavirus (COVID-19) Update: Daily Roundup
SILVER SPRING, Md., July 27, 2020
SILVER SPRING, Md., July 27, 2020 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
Media Contact: Lee.Herring@fda.hhs.gov
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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.
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SOURCE U.S. Food and Drug Administration
- On July 24, 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 symptoms or who have no reason to suspect COVID-19 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 FDA continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol. 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.
- On July 24, 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 by reviewing and approving generic medicines, such as anti-coagulants, used in the prevention and treatment of blood clotting.
- On July 24, 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:
- Testing updates:
- FAQs on Testing for SARS-CoV-2
- Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
- Coronavirus Disease 2019 (COVID-19)