{"id":46,"date":"2014-08-04T16:43:02","date_gmt":"2014-08-04T20:43:02","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=46"},"modified":"2014-09-10T15:06:00","modified_gmt":"2014-09-10T19:06:00","slug":"fda-issues-draft-guidances-for-prior-approval-supplements-and-amendments-easily-correctable-deficiencies-under-gdufa","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/08\/04\/fda-issues-draft-guidances-for-prior-approval-supplements-and-amendments-easily-correctable-deficiencies-under-gdufa\/","title":{"rendered":"FDA Issues Draft Guidances for Prior Approval Supplements and Amendments \/ Easily Correctable Deficiencies Under GDUFA"},"content":{"rendered":"<p>The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort &#8220;to speed access to safe and effective generic drugs to the public and reduce costs to industry.&#8221; In July 2014, the U.S. Food and Drug Administration issued two draft Guidances for Industry: one relating to Prior Approval Supplements Under GDUFA and one relating to Amendments and Easily Correctable Deficiencies Under GDUFA.<\/p>\n<p><a href=\"http:\/\/www.duanemorris.com\/alerts\/fda_draft_guidances_prior_approval_supplements_easily_correctable_deficiencies_GDUFA_5272.html\" target=\"_blank\">Click here<\/a> to read the full <em>Alert<\/em> written by Duane Morris partner <a href=\"http:\/\/www.duanemorris.com\/attorneys\/frederickrball.html\" target=\"_blank\">Rick Ball<\/a> and associate <a href=\"http:\/\/www.duanemorris.com\/attorneys\/carolynaalenci.html\" target=\"_blank\">Carolyn Alenci<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Generic Drug User Fee Amendments of 2012 (GDUFA) were signed into law on July 9, 2012, in an effort &#8220;to speed access to safe and effective generic drugs to the public and reduce costs to industry.&#8221; In July 2014, the U.S. Food and Drug Administration issued two draft Guidances for Industry: one relating to &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/08\/04\/fda-issues-draft-guidances-for-prior-approval-supplements-and-amendments-easily-correctable-deficiencies-under-gdufa\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Issues Draft Guidances for Prior Approval Supplements and Amendments \/ Easily Correctable Deficiencies Under GDUFA&#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":[37,64,119],"ppma_author":[521],"class_list":["post-46","post","type-post","status-publish","format-standard","hentry","category-general","tag-anda","tag-guidance","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\/46","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=46"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/46\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=46"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=46"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=46"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=46"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}