{"id":122,"date":"2018-11-09T17:21:59","date_gmt":"2018-11-09T21:21:59","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=122"},"modified":"2018-11-09T17:21:59","modified_gmt":"2018-11-09T21:21:59","slug":"cders-new-mapp-on-risk-based-site-selection-model-for-routine-inspections","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2018\/11\/09\/cders-new-mapp-on-risk-based-site-selection-model-for-routine-inspections\/","title":{"rendered":"CDER&#8217;s New MAPP on Risk-Based Site Selection Model for Routine Inspections"},"content":{"rendered":"<p>The Food and Drug Administration\u2019s Center for Drug Evaluation and Research (CDER) published a new\u00a0<a href=\"https:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CDER\/ManualofPoliciesProcedures\/UCM619302.pdf\" target=\"_blank\" rel=\"noopener\">Manual of Policies and Procedures<\/a>\u00a0(MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (<i>i.e.,<\/i>\u00a0equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA\u2019s resources.<\/p>\n<p><a href=\"https:\/\/www.duanemorris.com\/alerts\/cder_new_mapp_risk_based_site_selection_model_routine_inspections_1118.html\" target=\"_blank\" rel=\"noopener\">We invite you to read the full text of this <em>Duane Morris Alert<\/em> on the firm website.<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Food and Drug Administration\u2019s Center for Drug Evaluation and Research (CDER) published a new\u00a0Manual of Policies and Procedures\u00a0(MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2018\/11\/09\/cders-new-mapp-on-risk-based-site-selection-model-for-routine-inspections\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;CDER&#8217;s New MAPP on Risk-Based Site Selection Model for Routine Inspections&#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":[317,316,319,318,221,320,321,322],"ppma_author":[521],"class_list":["post-122","post","type-post","status-publish","format-standard","hentry","category-general","tag-cder","tag-food-and-drug-administrations-center-for-drug-evaluation-and-research","tag-good-manufacturing-practices","tag-inspection","tag-life-sciences","tag-manual-of-policies-and-procedures","tag-mapp","tag-pharmaceuticals"],"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\/122","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=122"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/122\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=122"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=122"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=122"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=122"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}