{"id":147,"date":"2019-05-16T12:22:54","date_gmt":"2019-05-16T16:22:54","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=147"},"modified":"2019-05-16T12:25:07","modified_gmt":"2019-05-16T16:25:07","slug":"fda-releases-draft-guidance-on-voluntary-recalls-comments-due-june-24","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/05\/16\/fda-releases-draft-guidance-on-voluntary-recalls-comments-due-june-24\/","title":{"rendered":"FDA Releases Draft Guidance on Voluntary Recalls &#8211; Comments Due June 24"},"content":{"rendered":"<p>The Food and Drug Administration (FDA) recently released a\u00a0<a title=\"Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C Guidance for Industry and FDA Staff \" href=\"https:\/\/www.regulations.gov\/document?D=FDA-2018-D-2074-0002\" target=\"_blank\" rel=\"noopener noreferrer\">draft guidance<\/a>\u00a0on voluntary recalls urging companies to institute recall plans and procedures in advance to ensure quick and effective execution when a recall is necessary: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA broke the guidance into four main parts: (1) preparation for a recall; (2) response to a reported problem with a product; (3) initiation of a recall; and (4) FDA\u2019s role in initiation of a recall. As firms develop plans for voluntary recalls, we recommend that they consult with counsel to ensure that they comply with regulatory requirements and appropriately address the concerns raised by the FDA in this draft guidance.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_releases_draft_guidance_voluntary_recalls_0519.html\">View the full <em>Alert<\/em> on the Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration (FDA) recently released a\u00a0draft guidance\u00a0on voluntary recalls urging companies to institute recall plans and procedures in advance to ensure quick and effective execution when a recall is necessary: Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. FDA broke the guidance into four main parts: (1) preparation for &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/05\/16\/fda-releases-draft-guidance-on-voluntary-recalls-comments-due-june-24\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Releases Draft Guidance on Voluntary Recalls &#8211; Comments Due June 24&#8221;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":[29,64,221,50,119,367,369],"ppma_author":[521],"class_list":["post-147","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-fda","tag-guidance","tag-life-sciences","tag-pharma","tag-rick-ball","tag-ryan-wesley-brown","tag-voluntary-recall"],"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\/147","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=147"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/147\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=147"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=147"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=147"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=147"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}