{"id":16021,"date":"2020-05-02T08:45:42","date_gmt":"2020-05-02T13:45:42","guid":{"rendered":"http:\/\/www.paristn.net\/articles\/?p=16021"},"modified":"2020-05-02T00:56:55","modified_gmt":"2020-05-02T05:56:55","slug":"fda-coronavirus-covid-19-update-may-2nd-2020","status":"publish","type":"post","link":"https:\/\/www.paristn.net\/articles\/2020\/05\/02\/fda-coronavirus-covid-19-update-may-2nd-2020\/","title":{"rendered":"FDA Coronavirus (COVID-19) Update: May 2nd, 2020"},"content":{"rendered":"

\"U.S.Silver Spring, MD<\/strong> – <\/span>The U.S. Food and Drug Administration continues to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:<\/p>\n

Friday, the FDA issued an Emergency Use Authorization (EUA) for the investigational antiviral drug remdesivir<\/a>.<\/p>\n

\"Coronavirus\"<\/a>

Coronavirus<\/p><\/div>\n

<\/p>\n

The EUA<\/a> allows for remdesivir to be distributed in the United States and administered by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 Coronavirus in adults and children hospitalized with severe disease.<\/p>\n

Severe disease is defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.<\/p>\n

Based on evaluation of the emergency use authorization criteria and the scientific evidence available, it was determined that it is reasonable to believe that remdesivir may be effective in treating COVID-19 Coronavirus, and that, given there are no adequate, approved, or available alternative treatments, the known and potential benefits to treat this serious or life-threatening virus currently outweigh the known and potential risks of the drug’s use.<\/p>\n

For more information see: news release<\/a>, Health Care Provider Fact Sheet<\/a> and Patient Fact Sheet<\/a>.<\/p>\n

Friday, the FDA updated its guidance<\/a> on convalescent plasma and associated web page<\/a>. The updated guidance provides clarification for investigators on how to submit investigational applications for COVID-19 Coronavirus convalescent plasma.<\/p>\n

In addition, the guidance includes updated information regarding potential donors. Previously, the FDA’s guidance noted that to qualify, individuals should have complete resolution of symptoms for 28 days or resolution for 14 and a negative diagnostic test. The revised guidance recommends that individuals  have complete resolution of symptoms for at least 14 days prior to donation<\/p>\n

A negative lab test for COVID-19 Coronavirus disease is not necessary to qualify for donation. The revised guidance also clarifies that FDA does not recommend storing a retention sample from the convalescent plasma donation for single patient emergency INDs.<\/p>\n

Given the many questions people have about grocery shopping safety, the FDA has posted a video, 12 Tips for Grocery Shopping During the Pandemic<\/a>,<\/u> to advise consumers.<\/p>\n

The FDA has also posted an updated COVID-19 Response At-A-Glance Summary<\/a>. It contains updates on major agency activities as well as some important facts and figures.<\/p>\n

To help address shortages of continuous renal replacement therapy (CRRT) products during the COVID-19 Coronavirus public health emergency, today the FDA issued an EUA to Fresenius Medical Care<\/a> for emergency use of the multiFiltrate PRO System and multiBic\/multiPlus Solutions. CRRT is a type of dialysis therapy used to filter and clean the blood when the kidneys are damaged or are not functioning normally. The Fresenius multiFiltrate PRO System and multiBic\/multiPlus Solutions have been authorized to provide CRRT to treat patients in an acute care environment during the COVID-19 public health emergency.<\/p>\n

Diagnostics update to date:<\/strong><\/p>\n