FDA Coronavirus (COVID-19) Update: August 5th, 2020

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:

FDA has updated its COVID-19 Drug Shortages Response webpage to provide information regarding in-use time for certain drugs during the COVID-19 Coronavirus 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 Coronavirus in people.

There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. The warning letter advised MMSTabs.com to take immediate corrective action to cease selling these unapproved and unauthorized products. Consumers concerned about COVID-19 Coronavirus 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 Coronavirus 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.

 

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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.

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.