{"id":142,"date":"2020-06-12T16:25:36","date_gmt":"2020-06-12T20:25:36","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/productsliability\/?p=142"},"modified":"2020-06-12T16:25:36","modified_gmt":"2020-06-12T20:25:36","slug":"new-fda-compliance-program-details-fda-expectations-for-inspections-of-cder-or-cdrh-led-combination-product-manufacturers","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/productsliability\/2020\/06\/12\/new-fda-compliance-program-details-fda-expectations-for-inspections-of-cder-or-cdrh-led-combination-product-manufacturers\/","title":{"rendered":"New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers"},"content":{"rendered":"<p>On June 4, 2020, the U.S. Food &amp; Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and co-packaged finished combination products\u2014led by either the Center for Drug Evaluation and Research or the Center for Devices and Radiological Health\u2014that include both (i) drug and device; or (ii) biological product and device constituent parts.\u00a0In addition, because the underlying 2017 Guidance was issued by OPD, CBER, CDER and CDRH collectively, the same principals would like apply to inspections\u00a0 in which CBER is the lead center.<\/p>\n<p>To read the full text of this Duane Morris <em>Alert<\/em>, please <a href=\"https:\/\/www.duanemorris.com\/alerts\/new_fda_compliance_program_details_fda_expectations_inspections_cder_cdrh_led_0620.html\" target=\"_blank\" rel=\"noopener noreferrer\">visit the firm website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On June 4, 2020, the U.S. Food &amp; Drug Administration implemented a compliance program, which explains how CGMP requirements are to be applied to combination products, the subject of a final guidance issued in January 2017. In particular, the new program document focuses on providing a framework for conducting inspections of manufacturers of single-entity and &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/productsliability\/2020\/06\/12\/new-fda-compliance-program-details-fda-expectations-for-inspections-of-cder-or-cdrh-led-combination-product-manufacturers\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;New FDA Compliance Program Details FDA Expectations for Inspections of CDER- or CDRH-Led Combination Product Manufacturers&#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":[99,100,98,12,101,102],"ppma_author":[110],"class_list":["post-142","post","type-post","status-publish","format-standard","hentry","category-general","tag-cgmp-requirements","tag-combination-products","tag-compliance","tag-fda","tag-inspections","tag-manufacturers"],"authors":[{"term_id":110,"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\/productsliability\/wp-json\/wp\/v2\/posts\/142","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/comments?post=142"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/posts\/142\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/media?parent=142"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/categories?post=142"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/tags?post=142"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/productsliability\/wp-json\/wp\/v2\/ppma_author?post=142"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}