{"id":174,"date":"2019-10-23T10:28:31","date_gmt":"2019-10-23T14:28:31","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=174"},"modified":"2019-10-23T10:28:31","modified_gmt":"2019-10-23T14:28:31","slug":"federal-agencies-issue-draft-guidance-for-drug-master-files-for-first-time-in-30-years","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/10\/23\/federal-agencies-issue-draft-guidance-for-drug-master-files-for-first-time-in-30-years\/","title":{"rendered":"Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years"},"content":{"rendered":"<p>For the first time since September 1989, federal agencies have issued\u00a0<a title=\"Drug Master Files Guidance for Industry\" href=\"https:\/\/www.fda.gov\/media\/131861\/download\" target=\"_blank\" rel=\"noopener noreferrer\">draft guidance<\/a>\u00a0concerning drug master files (DMFs), submissions to the FDA that may be used to provide confidential, detailed information concerning the manufacturing, processing, packaging and storing of human drug products. Notably, the release of this draft guidance comes on the heels of a recent executive order by President Trump aiming to curb the use of agency guidance documents to avoid the formal rule-making process.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/federal_agencies_issue_draft_guidance_drug_master_files_first_time_30_years_1019.html\">View the full <em>Alert<\/em> on the Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For the first time since September 1989, federal agencies have issued\u00a0draft guidance\u00a0concerning drug master files (DMFs), submissions to the FDA that may be used to provide confidential, detailed information concerning the manufacturing, processing, packaging and storing of human drug products. Notably, the release of this draft guidance comes on the heels of a recent executive &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2019\/10\/23\/federal-agencies-issue-draft-guidance-for-drug-master-files-for-first-time-in-30-years\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Federal Agencies Issue Draft Guidance for Drug Master Files for First Time in 30 Years&#8221;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":[409,29,64,388,298,119],"ppma_author":[521],"class_list":["post-174","post","type-post","status-publish","format-standard","hentry","category-uncategorized","tag-drug-master-files","tag-fda","tag-guidance","tag-justin-stern","tag-patrick-gallagher","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\/174","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=174"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/174\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=174"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=174"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=174"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=174"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}