{"id":15654,"date":"2020-04-02T06:30:31","date_gmt":"2020-04-02T11:30:31","guid":{"rendered":"http:\/\/www.paristn.net\/articles\/?p=15654"},"modified":"2020-04-01T23:49:50","modified_gmt":"2020-04-02T04:49:50","slug":"fda-coronavirus-covid-19-update-for-april-1st-2020","status":"publish","type":"post","link":"https:\/\/www.paristn.net\/articles\/2020\/04\/02\/fda-coronavirus-covid-19-update-for-april-1st-2020\/","title":{"rendered":"FDA Coronavirus (COVID-19) Update for April 1st, 2020"},"content":{"rendered":"<p><span class=\"xn-location\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-full wp-image-40850\" title=\"U.S. Food and Drug Administration - FDA\" src=\"https:\/\/www.clarksvilleonline.com\/wp-content\/uploads\/2010\/07\/fda.gif\" alt=\"U.S. Food and Drug Administration - FDA\" width=\"200\" height=\"81\"><strong>Silver Spring, MD<\/strong> &#8211; Last Wednesday, April 1st, 2020, t<\/span>he U.S. Food and Drug Administration (FDA) announced the following actions taken in its ongoing response effort to the Coronavirus (COVID-19) pandemic.<\/p>\n<p><a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2767261-1&amp;h=622666496&amp;u=https%3A%2F%2Fwww.fda.gov%2Fmedical-devices%2Fdatabase-reference-grade-microbial-sequences-fda-argos%2Ffda-argos-sars-cov-2-reference-grade-sequence-data&amp;a=FDA-ARGOS+SARS-CoV-2+Reference+Grade+Sequence+Data+Now+Available\"  target=\"_blank\" rel=\"nofollow noopener noreferrer\">FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available<\/a>: In response to the Coronavirus (COVID-19) pandemic, the FDA\u2014in collaboration with the U.S. Centers for Disease Control and Prevention (CDC), the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) and the Institute for Genome Sciences at the <span class=\"xn-org\">University of Maryland<\/span> and the National Center for Biotechnology Information (NCBI)\u2014developed quality-controlled, reference sequence data for the SARS-CoV-2 reference strain for <span class=\"xn-location\">the United States<\/span>.<\/p>\n<div id=\"attachment_482711\" style=\"width: 490px\" class=\"wp-caption aligncenter\"><a target=\"_blank\" href=\"https:\/\/www.clarksvilleonline.com\/wp-content\/uploads\/2020\/02\/Coronavirus.jpg\"  class=\"thickbox no_icon\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-482711\" class=\"size-medium wp-image-482711\" title=\"Coronavirus\" src=\"https:\/\/www.clarksvilleonline.com\/wp-content\/uploads\/2020\/02\/Coronavirus-480x240.jpg\" alt=\"Coronavirus\" width=\"480\" height=\"240\"><\/a><p id=\"caption-attachment-482711\" class=\"wp-caption-text\">Coronavirus<\/p><\/div>\n<p><!--more--><\/p>\n<h4>Availability of traceable and quality-controlled data will help test developers and vaccine developers:<\/h4>\n<ul>\n<li>Expedite development of medical countermeasures.<\/li>\n<li>Identify new or more stable targets for future tests.<\/li>\n<li>Enable in silico confirmation of targets.<\/li>\n<li>Support development of synthetic reference material.<\/li>\n<li>Enable viral population\/quasi species analysis.<\/li>\n<\/ul>\n<p>The FDA issued a <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2767261-1&amp;h=107242476&amp;u=https%3A%2F%2Fwww.fda.gov%2Ffood%2Fcfsan-constituent-updates%2Ffda-provides-flexibility-regarding-menu-labeling-requirements-chain-restaurants-and-similar-retail&amp;a=Constituent+Update\"  target=\"_blank\" rel=\"nofollow noopener noreferrer\">Constituent Update<\/a>&nbsp;regarding <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2767261-1&amp;h=2827534373&amp;u=https%3A%2F%2Fwww.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Ftemporary-policy-regarding-nutrition-labeling-standard-menu-items-chain-restaurants-and-similar&amp;a=guidance\"  target=\"_blank\" rel=\"nofollow noopener noreferrer\">guidance<\/a>&nbsp;it released today to provide temporary flexibility to chain restaurants and similar retail food establishments currently required to provide nutrition information, including calories, on menus and menu boards.<\/p>\n<p>The FDA is continuing to issue warning letters to companies for selling fraudulent Coronavirus (COVID-19) products, as part of the agency&#8217;s effort to protect consumers. FDA and FTC issued a <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2767261-1&amp;h=1191104354&amp;u=https%3A%2F%2Fwww.fda.gov%2Finspections-compliance-enforcement-and-criminal-investigations%2Fwarning-letters%2Fneuroxpf-606236-03312020&amp;a=warning+letter\"  target=\"_blank\" rel=\"nofollow noopener noreferrer\">warning letter<\/a>&nbsp;to Neuro XPF, which sells cannabidiol (CBD) products in the U.S. with the misleading claim these products can mitigate, prevent, treat, diagnose, or cure COVID-19. The agency will continue to pursue those that place public health at risk.<\/p>\n<p>Diagnostics update to date: During the Coronavirus (COVID-19) pandemic, the FDA has worked 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. To date, 23 <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2767261-1&amp;h=2795832422&amp;u=https%3A%2F%2Fwww.fda.gov%2Fmedical-devices%2Femergency-situations-medical-devices%2Femergency-use-authorizations&amp;a=emergency+use+authorizations\"  target=\"_blank\" rel=\"nofollow noopener noreferrer\">emergency use authorizations<\/a>&nbsp;have been issued for diagnostic tests.<\/p>\n<p>On <span class=\"xn-chron\">March 31st<\/span> FDA <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2767261-1&amp;h=1491334975&amp;u=https%3A%2F%2Fwww.fda.gov%2Fmedical-devices%2Femergency-situations-medical-devices%2Femergency-use-authorizations%23covid19ivd&amp;a=issued+an+EUA\"  target=\"_blank\" rel=\"nofollow noopener noreferrer\">issued an EUA<\/a>&nbsp;that authorizes eligible molecular-based laboratory developed tests, or LDTs, that are developed and used by a single CLIA high complexity laboratory. Under this EUA, FDA has authorized Yale New Haven Hospital&#8217;s SARS-CoV-2 PCR test.<\/p>\n<p>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 U.S. Food and Drug Administration (FDA) also continues to keep its <a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2767261-1&amp;h=1025245841&amp;u=https%3A%2F%2Fwww.fda.gov%2Fmedical-devices%2Femergency-situations-medical-devices%2Ffaqs-diagnostic-testing-sars-cov-2&amp;a=COVID-19+Diagnostics+FAQ\"  target=\"_blank\" rel=\"nofollow noopener noreferrer\">COVID-19 Diagnostics FAQ<\/a>&nbsp;up to date.<\/p>\n<p><b>Additional Resources:<\/b><\/p>\n<ul>\n<li><a href=\"https:\/\/c212.net\/c\/link\/?t=0&amp;l=en&amp;o=2767261-1&amp;h=1809931733&amp;u=https%3A%2F%2Fwww.fda.gov%2Femergency-preparedness-and-response%2Fcounterterrorism-and-emerging-threats%2Fcoronavirus-disease-2019-covid-19&amp;a=Coronavirus+Disease+2019+(COVID-19)\"  target=\"_blank\" rel=\"nofollow noopener noreferrer\">Coronavirus Disease 2019 (COVID-19)<\/a><\/li>\n<\/ul>\n<p><br class=\"dnr\"><b>Consumer Inquiries<\/b>: 888.INFO.FDA<\/p>\n<h3>About the U.S. Food and Drug Administration<\/h3>\n<p>The U.S. Food and Drug Administration (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&#8217;s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Silver Spring, MD &#8211; Last Wednesday, April 1st, 2020, the U.S. Food and Drug Administration (FDA) announced the following actions taken in its ongoing response effort to the Coronavirus (COVID-19) pandemic. FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available: In response to the Coronavirus (COVID-19) pandemic, the FDA\u2014in collaboration with the U.S. Centers for Disease [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"ngg_post_thumbnail":0,"footnotes":""},"categories":[181],"tags":[1297,12675,12782,12712,1110,9199,2729,12876,8987],"class_list":["post-15654","post","type-post","status-publish","format-standard","hentry","category-government","tag-cdc","tag-coronavirus","tag-coronavirus-test","tag-covid-19","tag-fda","tag-silver-spring-md","tag-u-s-centers-for-disease-control-and-prevention","tag-u-s-food-and-drug-administratin","tag-university-of-maryland"],"_links":{"self":[{"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/posts\/15654","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/comments?post=15654"}],"version-history":[{"count":1,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/posts\/15654\/revisions"}],"predecessor-version":[{"id":15655,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/posts\/15654\/revisions\/15655"}],"wp:attachment":[{"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/media?parent=15654"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/categories?post=15654"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.paristn.net\/articles\/wp-json\/wp\/v2\/tags?post=15654"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}