{"id":351,"date":"2019-03-17T14:39:14","date_gmt":"2019-03-17T05:39:14","guid":{"rendered":"https:\/\/info.zanet.biz\/?p=351"},"modified":"2019-03-17T17:39:36","modified_gmt":"2019-03-17T08:39:36","slug":"fda%e3%81%aebenefit-risk-assessment-framework","status":"publish","type":"post","link":"https:\/\/info.zanet.biz\/?p=351","title":{"rendered":"FDA\u306eBenefit-Risk Assessment Framework"},"content":{"rendered":"\n<p><a href=\"https:\/\/www.fda.gov\/\">FDA <\/a>U.S. Food and Drug Administration\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u306f2013\u5e74\u306bStructured Approach to Benefit-Risk Assessment in Drug Regulatory Decision-Making\u3068\u3044\u3046<a href=\"https:\/\/www.fda.gov\/downloads\/ForIndustry\/UserFees\/PrescriptionDrugUserFee\/UCM329758.pdf\">\u5b9f\u884c\u30d7\u30e9\u30f3<\/a>\u3092\u767a\u8868\u3057\u3066\u3044\u307e\u3059\u3002\u305d\u306e\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u304c2018\u5e743\u670830\u65e5\u306b<a href=\"https:\/\/www.fda.gov\/downloads\/ForIndustry\/UserFees\/PrescriptionDrugUserFee\/UCM602885.pdf\">Draft PDUFA VI Implementation Plan<\/a>\u3068\u3057\u3066\u767a\u8868\u3055\u308c\u3066\u3044\u307e\u3059\u3002\uff08PDUFA\u306f Prescription Drug User Fee Act\u306e\u3053\u3068\u3067\u3059\u3002\uff09\u3053\u306e\u6587\u66f8\u306e\u4e2d\u3067\u3001Benefit-Risk Framework (BRF)\u3092\u5f37\u5316\u3057\u3001\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u3092\u4fc3\u9032\u3059\u308b\u3053\u3068\u304cFDA\u306e\u4f7f\u547d\u306e\u3072\u3068\u3064\u3067\u3042\u308b\u3068\u8ff0\u3079\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>2016\u5e7412\u670816\u65e5\u306b\u767a\u52b9\u3057\u305fThe 21st Century Cures Act (Cures Act)\u306b\u3088\u3063\u3066\u3001\u8a31\u8a8d\u53ef\u306b\u95a2\u308f\u308b\u610f\u601d\u6c7a\u5b9a\u306b\u8cc7\u3059\u308b\u305f\u3081\u306b\u95a2\u4fc2\u306e\u3042\u308b\u60a3\u8005\u306e\u7d4c\u9a13\u306e\u30c7\u30fc\u30bf\u304a\u3088\u3073\u95a2\u9023\u306e\u3042\u308b\u60c5\u5831\u3092\u69cb\u9020\u5316\u3055\u308c\u305fBenefit-Risk Framework\u30d9\u30cd\u30d5\u30a3\u30c3\u30c8\u30fb\u30ea\u30b9\u30af\u30a2\u30bb\u30b9\u30e1\u30f3\u30c8\u306e\u67a0\u7d44\u307f\u306b\u3092\u53d6\u308a\u5165\u308c\u308b\u3053\u3068\u306b\u5bfe\u3057\u3066FDA\u306f\u3069\u306e\u3088\u3046\u306b\u671f\u5f85\u3057\u3066\u3044\u308b\u304b\u3092\u8ff0\u3079\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u3092\u51fa\u3059\u3053\u3068\u304c\u6c42\u3081\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n\n\n\n<p>\u73fe\u6642\u70b9\u3067\u3001<a href=\"https:\/\/www.raps.org\/regulatory-focus\u2122\/news-articles\/2017\/9\/quantitative-benefit-risk-assessment-fda-officials-detail-key-considerations\">FDA Benefit-Risk Framework<\/a>\u306fDecision Factor\u3068\u3057\u3066Analysis of Condition, Current Treatment Options, Benefit, Risk, Risk Managment\u304c\u8a2d\u5b9a\u3055\u308c\u3066\u304a\u308a\u3001\u5404\u9805\u76ee\u306b\u5bfe\u3057\u3066Evidence and Uncertainties\u3068Conclulsions and Reasons\u3092\u8a18\u8f09\u3057\u3001\u307e\u3068\u3081\u3068\u3057\u3066Benefit-Risk Summary Assessment\u3092\u8a18\u8f09\u3059\u308b\u3088\u3046\u306b\u4f5c\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FDA U.S. Food and Drug Administration\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\u306f2013\u5e74\u306bStructured Approach to Benefit-Risk Assessment in Drug Reg &hellip; <a href=\"https:\/\/info.zanet.biz\/?p=351\" class=\"more-link\"><span class=\"screen-reader-text\">&#8220;FDA\u306eBenefit-Risk Assessment Framework&#8221; \u306e<\/span>\u7d9a\u304d\u3092\u8aad\u3080<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[27,5,3],"tags":[],"class_list":["post-351","post","type-post","status-publish","format-standard","hentry","category-benefit-harm-assessment","category-cpg","category-mdm"],"_links":{"self":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/351","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=351"}],"version-history":[{"count":2,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/351\/revisions"}],"predecessor-version":[{"id":354,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=\/wp\/v2\/posts\/351\/revisions\/354"}],"wp:attachment":[{"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=351"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=351"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/info.zanet.biz\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=351"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}