{"id":16640,"date":"2012-06-01T11:30:47","date_gmt":"2012-06-01T11:30:47","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=16640"},"modified":"2012-07-21T05:41:53","modified_gmt":"2012-07-21T05:41:53","slug":"fda-advisory-panel-vote-131-for-approval-of-quad","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/16640","title":{"rendered":"FDA advisory panel vote 13:1 for approval of Quad"},"content":{"rendered":"<p><strong>On 11 May 2012, the US FDA Antiviral Drugs Advisory Committee held an open meeting to decide on recommendations for approval for the 4-in-1, fixed dose combination (FDC) Quad (elvitegravir\/cobicistat\/tneofovir\/FTC), manufactured by Gilead.<\/strong><\/p>\n<p>The panel voted 13:1 in favour of recommending approval. The vote against came from a nephrologist and was based on the current availability of existing options for which there is more established renal safety data.<\/p>\n<p>The FDA nearly always follows panel recommendations though this is not mandatory.<\/p>\n<p>As part of this process, the FDA publish a briefing document prior to each advisory panel meeting, available in PDF format online, which compiles a review of the data.<\/p>\n<p>Links and further information:<\/p>\n<p>FDA briefing document: 200-page new drug application (PDF)<\/p>\n<p><a href=\"http:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/Drugs\/AntiviralDrugsAdvisoryCommittee\/UCM303397.pdf?\">http:\/\/www.fda.gov\/downloads\/AdvisoryCommittees\/CommitteesMeetingMaterials\/<br \/>\nDrugs\/AntiviralDrugsAdvisoryCommittee\/UCM303397.pdf?<\/a><\/p>\n<p>Gilead PR. FDA committee supports approval of Gilead&#8217;s once-daily Quad single tablet regimen for HIV (11 May 2012)<\/p>\n<p><a href=\"http:\/\/xa.yimg.com\/kq\/groups\/9246722\/1343919779\">http:\/\/xa.yimg.com\/kq\/groups\/9246722\/1343919779<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 11 May 2012, the US FDA Antiviral Drugs Advisory Committee held an open meeting to decide on recommendations for approval for the 4-in-1, fixed dose combination (FDC) Quad (elvitegravir\/cobicistat\/tneofovir\/FTC), manufactured by Gilead. The panel voted 13:1 in favour of &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-16640","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/16640","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=16640"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/16640\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=16640"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=16640"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=16640"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}