{"id":12385,"date":"2016-12-08T10:55:21","date_gmt":"2016-12-08T10:55:21","guid":{"rendered":"http:\/\/www.re-check.ch\/wordpress\/?p=12385"},"modified":"2019-06-11T11:41:03","modified_gmt":"2019-06-11T11:41:03","slug":"le-21st-century-cures-act-passera-t-il-le-senat-us","status":"publish","type":"post","link":"https:\/\/www.re-check.ch\/fr\/le-21st-century-cures-act-passera-t-il-le-senat-us\/","title":{"rendered":"Le 21st Century Cures Act passe le S\u00e9nat US"},"content":{"rendered":"<p class=\"p1\"><span class=\"s1\">Le 21st Century Cures Act a pass\u00e9 le S\u00e9nat US. C\u2019est une mauvaise nouvelle pour la sant\u00e9 des patients, car cela signifie que le mod\u00e8le \u00abinnovant\u00bb d\u2019AMM inaugur\u00e9 avec Gardasil\u00ae en 2006 sera g\u00e9n\u00e9ralis\u00e9. On rappellera en quoi \u00e7a consiste: accorder une <i>fast track<\/i> sans qu\u2019aucun crit\u00e8re <i>fast track<\/i> ne soit rempli, puis invoquer la <i>fast track<\/i> pour justifer le choix incompr\u00e9hensible des moins bons outcomes pour les \u00e9tudes de phase III. Le sigle \u00abFDA approved\u00bb risque d\u00e9finitivement de devenir synonyme de \u00abvery bad approval\u00bb.<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Il y en a d\u2019autres, en revanche, qui se frottent les mains&#8230;<\/span><\/p>\n<p class=\"p1\"><span class=\"s1\">Quelque chose de comparable ne devrait pas tarder \u00e0 arriver chez nous: aujourd\u2019hui, on discute AMM adaptatives (<a href=\"https:\/\/www.facebook.com\/hashtag\/adaptivepathways?source=feed_text&amp;story_id=10211187920634478\"><span class=\"s2\">#AdaptivePathways<\/span><\/a>) \u00e0 l\u2019EMA. NB: hors de tout contr\u00f4le d\u00e9mocratique.<\/span><\/p>\n<p class=\"p3\"><span class=\"s3\"><a href=\"http:\/\/Article\">https:\/\/www.statnews.com\/2016\/12\/01\/21st-century-cures-act-fda-approval\/<\/a><\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Le 21st Century Cures Act a pass\u00e9 le S\u00e9nat US. C\u2019est une mauvaise nouvelle pour la sant\u00e9 des patients, car cela signifie que le mod\u00e8le \u00abinnovant\u00bb d\u2019AMM inaugur\u00e9 avec Gardasil\u00ae en 2006 sera g\u00e9n\u00e9ralis\u00e9. On rappellera en quoi \u00e7a consiste: accorder une fast track sans qu\u2019aucun crit\u00e8re fast track ne soit rempli, puis invoquer la<a class=\"excerpt-read-more\" href=\"https:\/\/www.re-check.ch\/fr\/le-21st-century-cures-act-passera-t-il-le-senat-us\/\" title=\"ReadLe 21st Century Cures Act passe le S\u00e9nat US\">&#8230; Read more &raquo;<\/a><\/p>\n","protected":false},"author":1,"featured_media":12386,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[105,119,115,103],"tags":[],"class_list":["post-12385","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-conflits-dinterets-conflict-of-interest-fr","category-essais-cliniques-clinical-trials-fr","category-homologations-approvals-fr","category-methodologie-methodology-fr"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/posts\/12385"}],"collection":[{"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/comments?post=12385"}],"version-history":[{"count":2,"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/posts\/12385\/revisions"}],"predecessor-version":[{"id":12403,"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/posts\/12385\/revisions\/12403"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/media\/12386"}],"wp:attachment":[{"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/media?parent=12385"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/categories?post=12385"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.re-check.ch\/fr\/wp-json\/wp\/v2\/tags?post=12385"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}