{"id":36152,"date":"2013-04-13T20:37:47","date_gmt":"2013-04-14T00:37:47","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=36152"},"modified":"2013-04-13T20:37:47","modified_gmt":"2013-04-14T00:37:47","slug":"fda-schedules-another-2-day-avandia-advisory-panel","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2013\/04\/13\/fda-schedules-another-2-day-avandia-advisory-panel\/","title":{"rendered":"FDA Schedules Another 2-Day Avandia Advisory Panel"},"content":{"rendered":"<p>Once again the controversial diabetes drug rosiglitazone (Avandia,\u00a0GlaxoSmithKline) will be the subject of a 2-day FDA hearing. According to\u00a0<a href=\"https:\/\/s3.amazonaws.com\/public-inspection.federalregister.gov\/2013-08744.pdf\">a meeting announcement<\/a>\u00a0scheduled to be published in the Federal Register on April 15, the\u00a0Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and\u00a0Risk\u00a0Management\u00a0Advisory Committee will meet on June 5 and June 6 to \u00a0&#8220;discuss the results of an independent readjudication of the Rosiglitazone Evaluated for Cardiovascular Outcomes and\u00a0Regulation\u00a0of Glycemia in Diabetes (RECORD) trial.&#8221;<\/p>\n<p>The RECORD trial was one of the major topics of contention at the 2010 rosiglitazone advisory panel.\u00a0Designed ostensibly to test the effect of rosiglitazone on cardiovascular outcomes, RECORD was the subject of intense and often brutal criticism from FDA reviewers and Steve Nissen. One result of the 2010 panel was that GSK commissioned\u00a0Duke University\u00a0to perform an independent review and analysis of RECORD. This review will apparently be the subject of the June meeting.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Once again the controversial diabetes drug rosiglitazone (Avandia,\u00a0GlaxoSmithKline) will be the subject of a 2-day FDA hearing. According to\u00a0a meeting announcement\u00a0scheduled to be published in the Federal Register on April 15, the\u00a0Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and\u00a0Risk\u00a0Management\u00a0Advisory Committee will meet on June 5 and June 6 to \u00a0&#8220;discuss the results [&hellip;]<\/p>\n","protected":false},"author":196,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1,7],"tags":[199,196,204,205],"class_list":["post-36152","post","type-post","status-publish","format-standard","hentry","category-general","category-prevention","tag-avandia","tag-fda","tag-record","tag-rosiglitazone"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/36152","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/196"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=36152"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/36152\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=36152"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=36152"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=36152"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}