{"id":55,"date":"2014-06-20T10:54:46","date_gmt":"2014-06-20T14:54:46","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=55"},"modified":"2014-09-10T15:37:15","modified_gmt":"2014-09-10T19:37:15","slug":"fda-releases-guidance-for-industry-on-andas-stability-testing-of-drug-substances-and-products-questions-and-answers","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/06\/20\/fda-releases-guidance-for-industry-on-andas-stability-testing-of-drug-substances-and-products-questions-and-answers\/","title":{"rendered":"FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers"},"content":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled <a href=\"http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM366082.pdf\" target=\"_blank\"><em>ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers<\/em><\/a>, which provides answers to questions from public comments received on the draft Guidance for Industry on <em>ANDAs: Stability Testing of Drug Substances and Products<\/em> (&#8220;FDA stability guidance&#8221;) that was published in the<em> Federal Register<\/em> on September 25, 2012. It also incorporates comments received on the same draft, which were previously published in the <em>Federal Register<\/em> on August 27, 2013.<\/p>\n<p><a href=\"http:\/\/www.duanemorris.com\/alerts\/fda_releases_guidance_for_industry_on_ANDAs_5231.html\" target=\"_blank\">Click here<\/a> to read this<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\/emilynwinfield.html\" target=\"_blank\">Emily Winfield<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) recently published a new Guidance for Industry, titled ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers, which provides answers to questions from public comments received on the draft Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products (&#8220;FDA stability guidance&#8221;) that was &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2014\/06\/20\/fda-releases-guidance-for-industry-on-andas-stability-testing-of-drug-substances-and-products-questions-and-answers\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Releases Guidance for Industry on ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers&#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":[37,186,29,64,119],"ppma_author":[521],"class_list":["post-55","post","type-post","status-publish","format-standard","hentry","category-general","tag-anda","tag-emily-winfield","tag-fda","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\/55","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=55"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/55\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=55"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=55"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=55"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=55"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}