{"id":156,"date":"2019-08-12T12:26:22","date_gmt":"2019-08-12T16:26:22","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=156"},"modified":"2019-08-12T12:26:22","modified_gmt":"2019-08-12T16:26:22","slug":"fda-releases-guidance-on-rems-modifications-and-revisions","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/08\/12\/fda-releases-guidance-on-rems-modifications-and-revisions\/","title":{"rendered":"FDA Releases Guidance on REMS Modifications and Revisions"},"content":{"rendered":"<p>On July 9, 2019, the U.S. Food and Drug Administration (FDA) released a\u00a0<a title=\"Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry\" href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/risk-evaluation-and-mitigation-strategies-modifications-and-revisions-guidance-industry-0\" target=\"_blank\" rel=\"noopener noreferrer\">final guidance<\/a>\u00a0on changes to approved Risk Evaluation and Mitigation Strategies (REMS). For certain drugs, the FDA may require a REMS as an additional risk management plan to ensure that the benefits of the drug outweigh the risks. The final guidance describes the three different types of changes to an approved REMS, how application holders should submit changes to REMS, and how the FDA will process submissions from application holders for changes to REMS.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_releases_guidance_rems_modifications_revisions_0819.html\">View the full <em>Alert<\/em> on the Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On July 9, 2019, the U.S. Food and Drug Administration (FDA) released a\u00a0final guidance\u00a0on changes to approved Risk Evaluation and Mitigation Strategies (REMS). For certain drugs, the FDA may require a REMS as an additional risk management plan to ensure that the benefits of the drug outweigh the risks. The final guidance describes the three &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/08\/12\/fda-releases-guidance-on-rems-modifications-and-revisions\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Releases Guidance on REMS Modifications and Revisions&#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":[1],"tags":[385,29,65,64,197,119],"ppma_author":[521],"class_list":["post-156","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-evan-muller","tag-fda","tag-final-guidance","tag-guidance","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\/156","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=156"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/156\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=156"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=156"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=156"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=156"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}