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FDA Actions In Response To COVID-19 - Update

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Providing an update on actions taken in response to the ongoing COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) announced it started a new program to expedite the development of potentially safe and effective life-saving treatments. It is also addressing the shortage of hydroxychloroquine and chloroquine as well as diagnostic tests.

Across the United States, confirmed coronavirus cases have exceeded 189,600 and the death toll has risen to nearly 4,100, as of this writing. New York is the worst-hit state in the U.S. Worldwide, more than 873,700 people have been infected and over 43,200 people have died of the novel coronavirus so far.

The FDA has started the Coronavirus Treatment Acceleration Program (CTAP). In this, every tool at the FDA's disposal will be used to bring new therapies to sick patients as quickly as possible.

The agency is redeploying staff and working day and night to review requests from companies, scientists and doctors who are working to develop new drug and biologic therapies.

The new program is expecged to help expedite the development of potentially safe and effective life-saving treatments for patients infected with this novel coronavirus.

For addressing the shortage of hydroxychloroquine and chloroquine, the FDA has added the two anti-malaria drugs to its "drug shortages webpage" due to a significant surge in demand. It is also working with manufacturers to assess their supplies.

Manufacturers such as Teva and Amneal as well as Mylan have ramped up production to provide additional supplies of the medication to the commercial market to ensure these drugs also remain available for patients dependent on them for treatment of malaria, lupus and rheumatoid arthritis.

The U.S. Department of Health and Human Services (HHS) has already received millions of doses of hydroxychloroquine sulfate donated by Sandoz, the Novartis generics and biosimilars division, and Bayer Pharmaceuticals, for use in treating patients hospitalized with COVID-19 or for use in clinical trials.

The FDA is also working with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. It has already issued two additional EUA's for COVID-19 diagnostics on Monday, for a total of 22 authorized tests.

The FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in its COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.

Additionally, the FDA and FTC also sent out additional warning letters to companies selling fraudulent products. The regulators issued the letters to three companies - Halosense Inc., Bioactive C60/FullerLifeC60 LLC and JRB Enterprise Group Inc. - for allegedly selling unapproved products by making unsupported claims that the products can treat, prevent, mitigate, diagnose or cure coronavirus (COVID-19).

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