SILVER SPRING, Md.,
March 30, 2020 /PRNewswire/ -- The
U.S. Food and Drug Administration today announced the following
actions taken in its ongoing response effort to the COVID-19
pandemic:
- On March 28, 2020, the FDA issued
an Emergency Use Authorization (EUA) to allow hydroxychloroquine
sulfate and chloroquine phosphate products donated to the Strategic
National Stockpile (SNS) to be distributed and used for certain
hospitalized patients with COVID-19. These drugs will be
distributed from the SNS to states for doctors to prescribe to
adolescent and adult patients hospitalized with COVID-19, as
appropriate, when a clinical trial is not available or feasible.
The EUA requires that fact sheets that provide important
information about using chloroquine phosphate and
hydroxychloroquine sulfate in treating COVID-19 be made available
to health care providers and patients, including the known risks
and drug interactions. The SNS, managed by ASPR, will work with the
Federal Emergency Management Agency (FEMA) to ship donated doses to
states.
- On March 29, 2020, the FDA issued
an immediately in effect guidance that outlines an enforcement
policy to help expand the availability and capability of
sterilizers, disinfectant devices and air purifiers. The devices
include those intended to make devices sterile, kill pathogens or
other microorganisms and kill pathogens or microorganisms in the
air. This policy reflects FDA's commitment to ease burdens on
health care providers and facilities as they face COVID-19.
- The FDA amended the Emergency Use Authorization (EUA) for the
Battelle Decontamination System for use in decontaminating
compatible N95 respirators for reuse by health care personnel
during the COVID-19 pandemic. This EUA is an important step forward
in helping to reduce shortages in critical N95 respirators, by
allowing for these important devices, when decontaminated, to be
reused by medical professionals on the front lines of the COVID-19
pandemic.
- On March 30, 2020, the FDA issued
an immediately in effect guidance to help expand the availability
of surgical apparel for health care professionals, including gowns
(togas), hoods, and surgeon's and patient examination gloves during
this public health emergency.
- FDA and FTC issued warning letters to two companies for selling
unapproved products claiming to mitigate, prevent, treat, diagnose
or cure COVID-19. One of the companies, Corona-cure.com, was warned
for selling the product Coronavirus Infection Prevention Nasal
Spray with misleading claims on its website that its product is
safe and/or effective for the treatment or prevention of COVID-19.
The agencies also warned Carahealth for selling its herbal
products, including "Carahealth Immune," with misleading claims of
prevention and/or treatment of COVID-19. We are particularly
concerned that unapproved drugs that claim to cure, treat, or
prevent serious conditions may cause consumers to delay or stop
appropriate medical treatment, leading to serious or
life-threatening harm. There is currently no approved treatment or
preventative measure for COVID-19. FDA and FTC are closely
monitoring social media, the online marketplace, and incoming
reports for fraudulent COVID-19 products on the market.
- The FDA issued an updated guidance, "Conduct of Clinical Trials
of Medical Products during COVID-19 Pandemic," with an appendix
adding questions and answers on this subject. We plan to update
this appendix as new questions arise. This guidance is intended for
industry, investigators and institutional review boards and was
issued because we recognize that the COVID-19 pandemic may impact
the conduct of clinical trials of medical products, including
drugs, devices and biological products.
- Diagnostics update to date: During the COVID-19 pandemic, the
FDA has worked with more than 230 test developers who have said
they will be submitting emergency use authorizations (EUA) requests
to FDA for tests that detect the virus. To date, 20 emergency use
authorizations have been issued for diagnostic tests, including
Abbott Diagnostics Scarborough, Inc., ID NOW COVID-19, a rapid (13
minutes or less) test. Additionally, the FDA has been notified that
more than 110 laboratories have begun testing under the policies
set forth in our COVID-19 Policy for Diagnostic Tests for
Coronavirus Disease-2019 during the Public Health Emergency
Guidance. The FDA also continues to keep its COVID-19 Diagnostics
FAQ up to date.
Additional Resources:
- Coronavirus Disease 2019 (COVID-19)
Media Contact: Stephanie
Caccomo, 301-348-1956
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