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:
-
- 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.
Additional Resources:
- FAQs on Testing for SARS-CoV-2
- Policy for Coronavirus Disease-2019 Tests During the Public
Health Emergency (Revised)
- Coronavirus Disease 2019 (COVID-19)
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