{"id":386,"date":"2023-08-10T11:27:32","date_gmt":"2023-08-10T15:27:32","guid":{"rendered":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=386"},"modified":"2023-08-10T11:27:32","modified_gmt":"2023-08-10T15:27:32","slug":"nitrosamine-impurities-fda-guidance","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2023\/08\/10\/nitrosamine-impurities-fda-guidance\/","title":{"rendered":"Nitrosamine Impurities FDA Guidance"},"content":{"rendered":"<p><em>By <a href=\"https:\/\/www.duanemorris.com\/attorneys\/alanklein.html\" target=\"_blank\" rel=\"noopener\">Alan Klein<\/a>, <a href=\"https:\/\/www.duanemorris.com\/attorneys\/patrickcgallagher.html\" target=\"_blank\" rel=\"noopener\">Patrick Gallagher<\/a> and <a href=\"https:\/\/www.duanemorris.com\/attorneys\/michaellfox.html\" target=\"_blank\" rel=\"noopener\">Michael Fox<\/a><\/em><\/p>\n<p>On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (<a href=\"https:\/\/www.fda.gov\/media\/170794\/download\" target=\"_blank\" rel=\"noopener\">Access the complete Guidance<\/a> or the\u00a0<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/recommended-acceptable-intake-limits-nitrosamine-drug-substance-related-impurities\" target=\"_blank\" rel=\"noopener\">abbreviated version.<\/a>)<\/p>\n<p>Reacting to considerable input from the pharmaceutical industry, both brand and generic, following the agency\u2019s Federal Register request for and receipt of extensive comments on these issues, including scientific data furnished to the agency by NDA and ANDA sponsors over the past year and a half, FDA has now provided drug manufacturers with critical guidelines for conforming their products to what the agency has determined to be safe nitrosamine exposure limits for patients. This comes on the heels of setting similar exposure limits for these products late last month by the European Union\u2019s chief drug regulator, the European Medicines Agency. In its current Guideline, FDA has ranked impacted prescription drugs into 5 categories depending upon their carcinogenic potency, with \u201c1\u201d being the most potent, and \u201c5\u201d the least. Instructing the industry on their responsibility to minimize or eliminate nitrosamine impurities in their products to the extent feasible, the agency has extended the timeline for this task to August 2025, recognizing the complexity of this process and the need to avoid recalls and market disruptions of widely prescribed and important medications.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>By Alan Klein, Patrick Gallagher and Michael Fox On August 4, 2023, the FDA issued a new Guidance to the pharmaceutical industry relating to large molecule drugs left unaddressed in its earlier nitrosamine Guidance publications. (Access the complete Guidance or the\u00a0abbreviated version.) Reacting to considerable input from the pharmaceutical industry, both brand and generic, following &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2023\/08\/10\/nitrosamine-impurities-fda-guidance\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Nitrosamine Impurities FDA Guidance&#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":[39,37,484,29,661,662,298,322],"ppma_author":[521],"class_list":["post-386","post","type-post","status-publish","format-standard","hentry","category-general","tag-alan-klein","tag-anda","tag-drug-manufacturers","tag-fda","tag-fda-guidance","tag-michael-fox","tag-patrick-gallagher","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\/386","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=386"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/386\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=386"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=386"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=386"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=386"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}