Coronavirus (COVID-19) Update: Daily Roundup
SILVER SPRING, Md., Aug. 4, 2020
SILVER SPRING, Md., Aug. 4, 2020 /PRNewswire/ -- 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:
Media Contact: Lee.Herring@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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