Coronavirus (COVID-19) Update: Daily Roundup August 4, 2020

Coronavirus (COVID-19) Update: Daily Roundup August 4, 2020

The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic: FDA has updated its COVID-19 Drug Shortages Response webpage to provide information regarding in-use time for certain drugs during the COVID-19 public health emergency. “In-use time” is the maximum amount of time that can be allowed to elapse between penetration of a container-closure system containing a sterile drug product, or after a lyophilized drug product has been reconstituted, and before patient administration. The information for health care facilities and providers on in-use time is intended to minimize the likelihood of physicochemical degradation or microbial proliferation during use in situations where a provider is considering use beyond the labeled in-use time for the specified products. As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to one company, MMSTabs.com, for selling unapproved and unauthorized products to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. The warning letter advised MMSTabs.com to take immediate corrective action to cease selling these unapproved and unauthorized products. Consumers concerned about COVID-19 should consult with their health care provider. FDA recently issued Emergency Use Authorizations (EUAs) to the following companies for their respective devices and tests: Abiomed, Inc., for its Impella Left Ventricular (LV) Support Systems to authorize the emergency use of the systems to provide temporary left-ventricle unloading and support to treat critical-care patients with confirmed COVID‐19 who are undergoing extracorporeal membrane oxygenation treatment; Cleveland Clinic Robert J. Tomsich Pathology and Laboratory Medicine Institute, for its (molecular) Cleveland Clinic SARS-Co-V-2 Assay; Poplar Healthcare, for its (molecular) Poplar SARS-CoV-2 TMA Pooling Assay; Wren Laboratories, LLC, for its (molecular) Wren Laboratories COVID-19 PCR Test; and Ethos Laboratories for its (molecular) SARS-CoV-2 MALDI-TOF Assay which can be used to test nasal swab specimens that are self-collected using the Ethos Laboratories U-Collect At Home Collections kit. Testing updates: To date, the FDA has currently authorized 203 tests under EUAs; these include 166 molecular tests, 35 antibody tests, and 2 antigen tests.