{"id":824,"date":"2020-08-27T17:43:52","date_gmt":"2020-08-27T21:43:52","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/coronaviruscovid19\/?p=824"},"modified":"2020-08-31T10:23:13","modified_gmt":"2020-08-31T14:23:13","slug":"fdas-thinking-on-imposition-of-civil-monetary-penalties-for-violations-of-clinical-trial-reporting-requirements-revealed-by-new-guidance","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/2020\/08\/27\/fdas-thinking-on-imposition-of-civil-monetary-penalties-for-violations-of-clinical-trial-reporting-requirements-revealed-by-new-guidance\/","title":{"rendered":"FDA&#8217;s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements Revealed by New Guidance"},"content":{"rendered":"<p>In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop\u2014and convince FDA of the safety and effectiveness of\u2014COVID-19 vaccines, therapeutics and diagnostic tests.<\/p>\n<p>To read the full text of this Duane Morris <em>Alert<\/em>, please <a href=\"https:\/\/www.duanemorris.com\/alerts\/new_guidance_reveals_fdas_thinking_imposition_civil_monetary_penalties_violations_clinical_0820.html\" target=\"_blank\" rel=\"noopener noreferrer\">visit the firm website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>In August 2020, the U.S. Food and Drug Administration issued guidance on the imposition of civil monetary penalties for violations of clinical trial reporting requirements. The new guidance is welcome insight for members of the pharmaceutical, biologics and medical device industries, particularly in light of the race to develop\u2014and convince FDA of the safety and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/2020\/08\/27\/fdas-thinking-on-imposition-of-civil-monetary-penalties-for-violations-of-clinical-trial-reporting-requirements-revealed-by-new-guidance\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA&#8217;s Thinking on Imposition of Civil Monetary Penalties for Violations of Clinical Trial Reporting Requirements Revealed by New Guidance&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[954,955,848,956,46,273,957,682],"ppma_author":[1043],"class_list":["post-824","post","type-post","status-publish","format-standard","hentry","category-general","tag-clinical-trial-reporting-requirements","tag-coronavirus","tag-covid-19","tag-covid-19-vaccine","tag-fda","tag-guidance","tag-life-sciences-and-medical-technologies","tag-testing"],"authors":[{"term_id":1043,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/posts\/824","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/comments?post=824"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/posts\/824\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/media?parent=824"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/categories?post=824"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/tags?post=824"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/coronaviruscovid19\/wp-json\/wp\/v2\/ppma_author?post=824"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}