{"id":67,"date":"2014-12-03T12:53:30","date_gmt":"2014-12-03T16:53:30","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=67"},"modified":"2014-12-03T12:53:30","modified_gmt":"2014-12-03T16:53:30","slug":"fda-report-on-standardizing-and-evaluating-risk-evaluation-and-mitigation-strategies-rems","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/12\/03\/fda-report-on-standardizing-and-evaluating-risk-evaluation-and-mitigation-strategies-rems\/","title":{"rendered":"FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)"},"content":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) recently published a report titled &#8220;<a href=\"http:\/\/www.fda.gov\/downloads\/ForIndustry\/UserFees\/PrescriptionDrugUserFee\/UCM415751.pdf?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery\" target=\"_blank\">Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS),<\/a>&#8221; which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA&#8217;s Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization.<\/p>\n<div id=\"fixedwidth\">\n<div id=\"content\">\n<div id=\"sidebar\">\n<div id=\"main\">\n<p>The report briefly reviews the background and context for REMS, as well as FDA management initiatives for REMS administration and program improvement; summarizes key perspectives expressed by stakeholders; and presents the design and proposed work plans of projects in four designated priority areas.<\/p>\n<p>To read the full text of the <em>Alert<\/em>, please visit the <a href=\"http:\/\/www.duanemorris.com\/alerts\/fda_report_on_standardizing_and_evaluating_risk_evaluation_and_mitigation_strategies_5384.html\">Duane Morris website<\/a>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) recently published a report titled &#8220;Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS),&#8221; which summarizes stakeholder engagements completed in fiscal year 2013 and fulfills FDA&#8217;s Prescription Drug User Fee Act (PDUFA) commitment to issue a report of its findings regarding REMS standardization. The report briefly reviews the &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/12\/03\/fda-report-on-standardizing-and-evaluating-risk-evaluation-and-mitigation-strategies-rems\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)&#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":[186,29,198,196,200,199,195,197,119],"ppma_author":[521],"class_list":["post-67","post","type-post","status-publish","format-standard","hentry","category-general","tag-emily-winfield","tag-fda","tag-patient","tag-pdufa","tag-pharmacy-systems","tag-prescriber-education","tag-prescription-drug-user-fee-act","tag-rems","tag-rick-ball"],"authors":[{"term_id":521,"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\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/67","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=67"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/67\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=67"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=67"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=67"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=67"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}