{"id":1778,"date":"2020-04-03T13:10:13","date_gmt":"2020-04-03T04:10:13","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/%e3%83%91%e3%83%b3%e3%83%87%e3%83%9f%e3%83%83%e3%82%af%e3%81%b8%e3%81%ae%e5%af%be%e5%bf%9c%ef%bc%9a%e5%8c%bb%e8%96%ac%e5%93%81%e3%81%ae%e9%81%a9%e5%bf%9c%e5%a4%96%e4%bd%bf%e7%94%a8%e3%80%81%e6%8b%a1\/?lang=ja"},"modified":"2020-04-03T13:10:13","modified_gmt":"2020-04-03T04:10:13","slug":"treating-a-pandemic-drug-repurposing-expanded-access-and-emergency-use-authorization-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/treating-a-pandemic-drug-repurposing-expanded-access-and-emergency-use-authorization-2\/","title":{"rendered":"\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u3078\u306e\u5bfe\u5fdc\uff1a\u533b\u85ac\u54c1\u306e\u9069\u5fdc\u5916\u4f7f\u7528\u3001\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u3001\u7dca\u6025\u6642\u306e\u4f7f\u7528\u8a31\u53ef"},"content":{"rendered":"<p><strong>MEG EGAN-AUDERSET<\/strong><\/p>\n<p><strong>Medical &amp; Regulatory Writer, Cortellis<\/strong><\/p>\n<p><strong>Clarivate<\/strong><\/p>\n<p><a href=\"https:\/\/clarivate.com\/cortellis\/blog\/treating-a-pandemic-drug-repurposing-expanded-access-and-emergency-use-authorization\/\">\u82f1\u8a9e\u539f\u6587<\/a><br \/>\nCOVID-19\u306e\u4e16\u754c\u7684\u306a\u5927\u6d41\u884c\u304c\u7d9a\u304f\u4e2d\u3001\u81e8\u5e8a\u5bb6\u3084\u653f\u6cbb\u5bb6\u306f\u3001SARS-CoV-2\u611f\u67d3\u75c7\u306e\u6cbb\u7642\u85ac\u3068\u3057\u3066\u3001\u3059\u3067\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u65e2\u77e5\u306e\u533b\u85ac\u54c1\u3092\u4f7f\u7528\u3059\u308b\u53ef\u80fd\u6027\u306b\u71b1\u5fc3\u306b\u5bfe\u5fdc\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u307e\u3060 COVID-19 \u306b\u7279\u5316\u3057\u3066 FDA \u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305f\u6cbb\u7642\u6cd5\u304c\u306a\u3044\u305f\u3081\u3001\u533b\u85ac\u54c1\u306e\u9069\u5fdc\u5916\u4f7f\u7528\u306f\u8003\u3048\u308b\u307e\u3067\u3082\u306a\u3044\u3088\u3046\u306b\u601d\u3048\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u3057\u304b\u3057\u3001\u533b\u85ac\u54c1\u306e\u9069\u5fdc\u5916\u4f7f\u7528\u306b\u306f\u30ea\u30b9\u30af\u304c\u306a\u3044\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3042\u308b\u9069\u5fdc\u75c7\u306b\u5bfe\u3057\u3066\u5b89\u5168\u304b\u3064\u6709\u52b9\u3067\u3042\u308b\u3068\u627f\u8a8d\u3055\u308c\u305f\u5316\u5408\u7269\u306e\u591a\u304f\u306f\u3001\u5225\u306e\u9069\u5fdc\u75c7\u306b\u5bfe\u3057\u3066\u306f\u52b9\u679c\u3082\u5b89\u5168\u6027\u3082\u3042\u308a\u307e\u305b\u3093\u3002\u6cbb\u7642\u6cd5\u306e\u6f5c\u5728\u7684\u306a\u5229\u70b9\u3068\u30ea\u30b9\u30af\u3092\u79e4\u91cf\u3059\u308b\u3053\u3068\u306f\u3001FDA\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306e\u4e0d\u53ef\u6b20\u306a\u90e8\u5206\u3067\u3042\u308a\u3001FDA\u306f\u975e\u5e38\u306b\u771f\u5263\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002\u4e16\u754c\u7684\u306a\u30a6\u30a4\u30eb\u30b9\u306e\u5927\u6d41\u884c\u306b\u76f4\u9762\u3057\u3066\u3082\u3001FDA\u306f\u3001\u516c\u8846\u885b\u751f\u306e\u4fdd\u8b77\u3068\u3044\u3046\u305d\u306e\u4e3b\u306a\u8cac\u4efb\u306b\u80cc\u304f\u3053\u3068\u304c\u306a\u3044\u3088\u3046\u306b\u3001\u305d\u306e\u57fa\u6e96\u3092\u4e0b\u3052\u308b\u3053\u3068\u3092\u671b\u3093\u3067\u3044\u307e\u305b\u3093\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306e\u9593\u306b\u6f5c\u5728\u7684\u306a\u6cbb\u7642\u6cd5\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b<\/strong><\/h4>\n<p>\u65b0\u3057\u3044\u9069\u5fdc\u75c7\u306e\u305f\u3081\u306b\u627f\u8a8d\u3055\u308c\u305f\u85ac\u3092\u518d\u5229\u7528\u3059\u308b\u3053\u3068\u306f\u3001\u78ba\u304b\u306b\u300c\u6cbb\u7642\u6cd5\u306e\u9078\u629e\u80a2\u304c\u307b\u3068\u3093\u3069\u306a\u3044\u3001\u307e\u305f\u306f\u306a\u3044\u75c5\u6c17\u3084\u6761\u4ef6\u306e\u6cbb\u7642\u306e\u305f\u3081\u306e\u52b9\u7387\u7684\u306a\u533b\u85ac\u54c1\u958b\u767a\u306e\u9053\u7b4b\u300d\u3067\u3042\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3001\u3068FDA\u306f\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u540c\u6a5f\u95a2\u306f2019\u5e7412\u6708\u306b\u3001\u9069\u5fdc\u5916\u4f7f\u7528\u306e\u53ef\u80fd\u6027\u3092\u63a2\u308b\u305f\u3081\u306e2\u65e5\u9593\u306e\u516c\u958b\u4f1a\u8b70\u3092\u5171\u50ac\u3057\u307e\u3057\u305f[FDA Workshop Bulletin: Addressing Obstacles to Repurposing Off-Patent Drugs, 05\/06-December-2019]\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u306b\u304a\u3044\u3066FDA\u306e\u8b1b\u6f14\u8005\u306f\u3001\u65b0\u85ac\u7533\u8acb\uff08NDA\uff09\u3001\u751f\u7269\u88fd\u5264\u30e9\u30a4\u30bb\u30f3\u30b9\u7533\u8acb\uff08BLA\uff09\u3001\u627f\u8a8d\u3055\u308c\u305fNDA\u3084BLA\u3078\u306e\u88dc\u8db3\u627f\u8a8d\u3092\u8ffd\u6c42\u3059\u308b\u305f\u3081\u306e\u5178\u578b\u7684\u306a\u898f\u5236\u30d1\u30b9\u30a6\u30a7\u30a4\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3057\u305f\u3002\u9069\u5fdc\u5916\u4f7f\u7528\u533b\u85ac\u54c1\u306b\u3064\u3044\u3066\u306f\u3001\u9023\u90a6\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5\uff08FD&amp;C\u6cd5\uff09\u306e\u7b2c505\u6761(b)(2)\u9805\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u300cintermediate pathway\u300d\u304c\u6700\u3082\u95a2\u9023\u6027\u304c\u9ad8\u3044\u3068\u8003\u3048\u3089\u308c\u308b\u3068\u306e\u3053\u3068\u3067\u3059\u3002505(b)(2)\u306e\u7533\u8acb\u306f\u3001\u901a\u5e38\u30011)\u4ee5\u524d\u306b\u627f\u8a8d\u3055\u308c\u305f\u533b\u85ac\u54c1\u306e\u5b89\u5168\u6027\u3068\u6709\u52b9\u6027\u306b\u3064\u3044\u3066\u306e\u4e8b\u524d\u306e\u77e5\u898b\u30012)\u516c\u8868\u3055\u308c\u305f\u6587\u732e\u306b\u57fa\u3065\u3044\u3066\u884c\u308f\u308c\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u660e\u3089\u304b\u306b\u3001\u3053\u308c\u3089\u306f\u300c\u5178\u578b\u7684\u306a\u300d\u72b6\u6cc1\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001FDA\u306e\u8fc5\u901f\u627f\u8a8d\u30d7\u30ed\u30b0\u30e9\u30e0\u3067\u3055\u3048\u3001\u3059\u3067\u306bSARS-CoV-2\u306b\u611f\u67d3\u3057\u3066\u3044\u308b\u4eba\u3005\u3092\u6cbb\u7642\u3059\u308b\u305f\u3081\u306b\u3001\u88fd\u54c1\uff08\u305f\u3068\u3048\u9069\u5fdc\u5916\u4f7f\u7528\u3055\u308c\u305f\u3082\u306e\u3067\u3042\u3063\u3066\u3082\uff09\u3092\u8fc5\u901f\u306b\u5e02\u5834\u306b\u9001\u308a\u51fa\u3059\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u308b\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3057\u304b\u3057\u3001COVID-19\u3092\u6cbb\u7642\u3059\u308b\u88fd\u54c1\u306e\u627f\u8a8d\u3092\u8fc5\u901f\u5316\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u53ef\u80fd\u6027\u304c\u3042\u308b\u65e2\u5b58\u306eFDA\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u9023\u90a6\u98df\u54c1\u533b\u85ac\u54c1\u5316\u7ca7\u54c1\u6cd5(FD&amp;C\u6cd5)\u306e\u7b2c505\u6761(b)(2)\u9805\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u300cintermediate pathway\u300d\u304c\u3001\u300c\u533b\u85ac\u54c1\u9069\u5fdc\u5916\u4f7f\u7528\u300d\u306e\u627f\u8a8d\u306b\u6700\u3082\u95a2\u9023\u3059\u308b\u624b\u6bb5\u3067\u3042\u308b\u3068\u8003\u3048\u3089\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u7dca\u6025\u4f7f\u7528\u627f\u8a8d\uff08EUA\uff09-FD&amp;C\u6cd5\u306e\u7b2c564\u6761\u306b\u306f\u3001\u5316\u5b66\u7684\u3001\u751f\u7269\u5b66\u7684\u3001\u653e\u5c04\u7dda\u5b66\u7684\u3001\u304a\u3088\u3073\u6838\uff08CBRN\uff09\u306e\u8105\u5a01\u306b\u5bfe\u3059\u308b\u516c\u8846\u885b\u751f\u4fdd\u8b77\u306e\u5f37\u5316\u3092\u76ee\u7684\u3068\u3057\u3066\u3001FDA\u306b\u3088\u308b\u533b\u7642\u5bfe\u7b56\uff08MCM\uff09\u306e\u78ba\u4fdd\u3068\u5229\u7528\u3092\u4fc3\u9032\u3059\u308b\u305f\u3081\u306eEUA\u6a29\u9650\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7b2c564\u6761\u3067\u306f\u3001\u7c73\u56fd\u4fdd\u5065\u798f\u7949\u7701\uff08HHS\uff09\u9577\u5b98\u304c\u3001CBRN\u306e\u8105\u5a01\u306b\u3088\u3063\u3066\u5f15\u304d\u8d77\u3053\u3055\u308c\u308b\u91cd\u7be4\u307e\u305f\u306f\u751f\u547d\u3092\u8105\u304b\u3059\u75be\u60a3\/\u75c7\u72b6\u306e\u8a3a\u65ad\u6cd5\u3001\u6cbb\u7642\u6cd5\u3001\u4e88\u9632\u6cd5\u3092\u7dca\u6025\u306b\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u6b63\u5f53\u5316\u3059\u308b\u300c\u7dca\u6025\u4e8b\u614b\u307e\u305f\u306f\u8105\u5a01\u300d\u3092\u5ba3\u8a00\u3057\u305f\u5834\u5408\u3001FDA\u306f\u672a\u627f\u8a8d\u306e\u533b\u85ac\u54c1\u306e\u4f7f\u7528\u3001\u307e\u305f\u306f\u627f\u8a8d\u533b\u85ac\u54c1\u306e\u9069\u5fdc\u5916\u306e\u4f7f\u7528\u3092\u8a31\u53ef\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19\u306e\u5834\u5408\u3001<\/p>\n<ul>\n<li>2020\u5e741\u670831\u65e5\u3001HHS\u9577\u5b98\u306f\u3001&#8221;2019\u5e74\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u306e\u78ba\u5b9a\u75c7\u4f8b\u306e\u7d50\u679c\u3068\u3057\u3066\u3001\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u304c\u7c73\u56fd\u306b\u5b58\u5728\u3059\u308b\u3053\u3068\u3092\u6b63\u5f0f\u306b\u6c7a\u5b9a\u3057\u307e\u3057\u305f\u3002&#8221; \u3057\u304b\u3057\u3001FDA\u304c\u6307\u6458\u3057\u305f\u3088\u3046\u306b\u3001<a href=\"https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-legal-regulatory-and-policy-framework\/emergency-use-authorization\/\" target=\"_blank\" rel=\"noopener\">\u3053\u306e\u5ba3\u8a00\u306b\u3088\u3063\u3066FDA\u306fEUA\u3092\u767a\u884c\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u305b\u3093\u3067\u3057\u305f<\/a>\u3002FDA\u306e\u30a2\u30af\u30b7\u30e7\u30f3\u306e\u305f\u3081\u306b\u306f\u3001\u9577\u5b98\u306fFD&amp;C\u6cd5\u7b2c564\u6761\u306e\u4e0b\u3067\u5225\u306e\u6c7a\u5b9a\u3068\u5ba3\u8a00\u3092\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/li>\n<li>2\u67084\u65e5\u3001\u9577\u5b98\u306fCOVID-19\u306b\u95a2\u3059\u308b\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u304c &#8220;<a href=\"https:\/\/www.federalregister.gov\/documents\/2020\/03\/10\/2020-04823\/emergency-use-declaration\/\" target=\"_blank\" rel=\"noopener\">\u56fd\u5bb6\u5b89\u5168\u4fdd\u969c\u307e\u305f\u306f\u6d77\u5916\u306b\u4f4f\u3080\u7c73\u56fd\u5e02\u6c11\u306e\u5065\u5eb7\u3068\u5b89\u5168\u4fdd\u969c\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u308b\u91cd\u5927\u306a\u53ef\u80fd\u6027\u304c\u3042\u308b<\/a>&#8220;\u3068\u5224\u65ad\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u5f8c\u3001\u305d\u306e\u6c7a\u5b9a\u306b\u57fa\u3065\u304dCOVID-19\u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306f\u3001SARS-CoV-2\u306e\u691c\u51fa\u304a\u3088\u3073\/\u307e\u305f\u306f\u8a3a\u65ad\u306e\u305f\u3081\u306e\u4f53\u5916\u8a3a\u65ad\u6cd5\u306e\u7dca\u6025\u4f7f\u7528\u3001\u304a\u3088\u3073 &#8220;\u500b\u4eba\u7528\u547c\u5438\u5668\u4fdd\u8b77\u88c5\u7f6e&#8221;\u306e\u7dca\u6025\u4f7f\u7528\u3092\u8a31\u53ef\u3059\u308b\u3053\u3068\u3092\u6b63\u5f53\u5316\u3059\u308b\u3068\u5ba3\u8a00\u3057\u307e\u3057\u305f\u3002<\/li>\n<li>3\u670810\u65e5\u3001HHS\u9577\u5b98\u306f\u3001Public Readiness and Emergency Preparedness Act (PREP\u6cd5)\u306b\u57fa\u3065\u304f<a href=\"https:\/\/www.phe.gov\/Preparedness\/legal\/prepact\/Pages\/COVID19.aspx\/\" target=\"_blank\" rel=\"noopener\">\u5ba3\u8a00<\/a>\u306e\u4e2d\u3067\u3001\u5bfe\u8c61\u3068\u306a\u308b\u5bfe\u7b56\u3092\u300c\u88fd\u9020\u3001\u914d\u5e03\u3001\u7ba1\u7406\u3001\u51e6\u65b9\u3001\u307e\u305f\u306f\u4f7f\u7528\u300d\u3059\u308b\u8005\u306b\u300cliability immunity\u300d\uff082020\u5e742\u67084\u65e5\u767a\u52b9\uff09\u3092\u62e1\u5927\u3057\u307e\u3057\u305f\u3002\u5ba3\u8a00\u3067\u306f\u3001\u300c\u5bfe\u8c61\u3068\u306a\u308b\u5bfe\u7b56\u300d\u3092\u300cCOVID-19\u3001\u307e\u305f\u306fSARS-CoV-2\u307e\u305f\u306f\u305d\u306e\u5909\u7570\u30a6\u30a4\u30eb\u30b9\u306e\u611f\u67d3\u306e\u6cbb\u7642\u3001\u8a3a\u65ad\u3001\u6cbb\u7652\u3001\u4e88\u9632\u3001\u8efd\u6e1b\u306b\u4f7f\u7528\u3055\u308c\u308b\u6297\u30a6\u30a4\u30eb\u30b9\u5264\u3001\u305d\u306e\u4ed6\u306e\u85ac\u5264\u3001\u751f\u7269\u5b66\u7684\u88fd\u5264\u3001\u8a3a\u65ad\u85ac\u3001\u305d\u306e\u4ed6\u306e\u88c5\u7f6e\u3001\u30ef\u30af\u30c1\u30f3\u3001\u307e\u305f\u306f\u305d\u306e\u3088\u3046\u306a\u88fd\u54c1\u306e\u6295\u4e0e\u306b\u4f7f\u7528\u3055\u308c\u308b\u88c5\u7f6e\u3001\u304a\u3088\u3073\u305d\u306e\u3088\u3046\u306a\u88fd\u54c1\u306e\u3059\u3079\u3066\u306e\u69cb\u6210\u8981\u7d20\u3068\u69cb\u6210\u6750\u6599\u300d\u3068\u5b9a\u7fa9\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>3\u670824\u65e5\u3001\u79d8\u66f8\u5b98\u306f\u300c\u533b\u7642\u6a5f\u5668\u3068\u3057\u3066\u4f7f\u7528\u3055\u308c\u308b\u4ee3\u66ff\u88fd\u54c1\u300d\u3001\u4eba\u5de5\u547c\u5438\u5668\u3001\u4eba\u5de5\u547c\u5438\u5668\u3068\u3057\u3066\u4f7f\u7528\u3059\u308b\u305f\u3081\u306b\u6539\u9020\u3055\u308c\u305f\u9ebb\u9154\u30ac\u30b9\u6a5f\u5668\u3001\u4eba\u5de5\u547c\u5438\u5668\u30c1\u30e5\u30fc\u30d6\u306e\u30b3\u30cd\u30af\u30bf\u30fc\u3001\u305d\u306e\u4ed6\u306e\u4ed8\u5c5e\u54c1\u3092\u542b\u3080\u3001\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u4e2d\u306e\u533b\u7642\u6a5f\u5668\u306e\u7dca\u6025\u4f7f\u7528\u3092\u8a8d\u3081\u308b\u306b\u8db3\u308b\u72b6\u6cc1\u304c\u3042\u308b\u3068\u5ba3\u8a00\u3057\u307e\u3057\u305f\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<p>FDA\u306f\u3059\u3067\u306b\u8907\u6570\u306eCOVID-19\u8a3a\u65ad\u30c6\u30b9\u30c8\u306b\u3064\u3044\u3066\u306eEUA\u3092\u767a\u884c\u3057\u3066\u304a\u308a\u3001\u5168\u56fd\u306e\u8a66\u9a13\u6240\u3084\u88fd\u9020\u4f1a\u793e\u304c\u4ed6\u306e\u30c6\u30b9\u30c8\u306e\u958b\u767a\u3084\u914d\u5e03\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\uff3bFDA Workshop Bulletin: FDA Policy for COVID-19 Diagnostic Tests, 25-March-2020]\u3002(\u6ce8\uff1aFDA\u306f\u3001COVID-19\u8a3a\u65ad\u85ac\u306eEUA\u627f\u8a8d\u30ea\u30b9\u30c8\u3092\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u66f4\u65b0\u3057\u3066\u3044\u307e\u3059)\u3002FDA\u306f\u307e\u305f\u3001\u7c73\u56fd\u52b4\u50cd\u5b89\u5168\u885b\u751f\u7814\u7a76\u6240\uff08NIOSH\uff09\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305f\u4f7f\u3044\u6368\u3066\u306e\u30d5\u30a3\u30eb\u30bf\u30fc\u5f0f\u9854\u9762\u547c\u5438\u5668\uff08FFR\uff09\u3068\u3001NIOSH\u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u3066\u3044\u306a\u3044\u300c\u7279\u5b9a\u306e\u300d\u8f38\u5165FFR\u306b\u5bfe\u3057\u3066\u3082EUA\u3092\u767a\u884c\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>FDA Expanded Access Program<\/strong><\/h4>\n<p>\u4e00\u822c\u7684\u306b\u300ccompassionate use\u300d\u3068\u547c\u3070\u308c\u308b<a href=\"https:\/\/clarivate.com\/cortellis\/tag\/fdas-expanded-access-program\/\">FDA\u306e\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0<\/a>\u306f\u3001\u6cbb\u9a13\u85ac\uff08IND\uff09\u306e\u81e8\u5e8a\u8a66\u9a13\u76ee\u7684\u5916\u306e\u4f7f\u7528\u3084\u3001\u30ea\u30b9\u30af\u8a55\u4fa1\u30fb\u7de9\u548c\u6226\u7565\uff08REMS\uff09\u306b\u3088\u3063\u3066\u5229\u7528\u304c\u5236\u9650\u3055\u308c\u3066\u3044\u308b\u533b\u85ac\u54c1\u306e\u4f7f\u7528\u3092\u53ef\u80fd\u306b\u3057\u3066\u3044\u307e\u3059\u300221 CFR 312, Subpart I\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u30d7\u30ed\u30b0\u30e9\u30e0\u306f&#8221;\u60a3\u8005\u306e\u91cd\u7be4\u306a\u75be\u60a3\u3084\u72b6\u614b\u3092\u8a3a\u65ad\u3001\u30e2\u30cb\u30bf\u30ea\u30f3\u30b0\u3001\u307e\u305f\u306f\u6cbb\u7642\u3059\u308b\u305f\u3081\u306e\u540c\u7b49\u307e\u305f\u306f\u6e80\u8db3\u306e\u3044\u304f\u4ee3\u66ff\u7642\u6cd5\u304c\u306a\u3044\u5834\u5408\u306b\u3001\u305d\u306e\u3088\u3046\u306a\u533b\u85ac\u54c1\u3092\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3059\u308b\u3053\u3068\u3092\u76ee\u7684\u3068\u3057\u3066\u3044\u308b &#8220;\u3068\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u306e\u57fa\u6e96\u306b\u306f\u3001\u300c\u60a3\u8005\u304c\u53d7\u3051\u308b\u6f5c\u5728\u7684\u306a\u5229\u76ca\u304c\u6cbb\u7642\u306e\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3092\u6b63\u5f53\u5316\u3059\u308b\u300d\u3068\u3044\u3046\u8981\u4ef6\u3068\u3001\u75be\u60a3\u3084\u72b6\u614b\u306b\u5bfe\u3057\u3066\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u304c\u300c\u4e0d\u5408\u7406\u3067\u306f\u306a\u3044\u300d\u3068\u3044\u3046\u8981\u4ef6\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002\u3055\u3089\u306b\u3001\u533b\u85ac\u54c1\u3078\u306e\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u306f\u3001\u540c\u3058\u7528\u9014\u306e\u533b\u85ac\u54c1\u306e\u627f\u8a8d\u3092\u652f\u6301\u3057\u3046\u308b\u81e8\u5e8a\u8a66\u9a13\u3092\u59a8\u5bb3\u3057\u3066\u306f\u306a\u308a\u307e\u305b\u3093\u3002FDA\u306f\u3001\u500b\u3005\u306e\u60a3\u8005\u3084\u60a3\u8005\u30b0\u30eb\u30fc\u30d7\u306b\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u3092\u9069\u7528\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u304c\u3001\u500b\u3005\u306e\u60a3\u8005\uff08\u7dca\u6025\u6642\u306e\u4f7f\u7528\u3092\u542b\u3080\uff09\u3001\u300c\u4e2d\u898f\u6a21\u300d\u306e\u60a3\u8005\u7fa4\u3001\u304a\u3088\u3073\u5e83\u7bc4\u56f2\u306e\u6cbb\u7642\u306b\u4f7f\u7528\u3059\u308b\u5834\u5408\u306e\u305d\u308c\u305e\u308c\u306b\u304a\u3044\u3066\u3001\u7279\u5b9a\u306e\u57fa\u6e96\u3092\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>\u73fe\u5728\u306e\u53d6\u308a\u7d44\u307f<\/strong><\/h4>\n<p>COVID-19\u306e\u6cbb\u7642\u6cd5\u306e\u4e00\u3064\u3068\u3057\u3066\u3001\u73fe\u5728\u7814\u7a76\u304c\u9032\u3081\u3089\u308c\u3066\u3044\u308b\u306e\u306f\u3001\u300cCOVID-19\u30a6\u30a4\u30eb\u30b9\u304b\u3089\u56de\u5fa9\u3057\u305f\u4eba\u3005\u304b\u3089\u63d0\u4f9b\u3055\u308c\u305f\u8840\u6db2\u304b\u3089\u63a1\u53d6\u3055\u308c\u308b\u6297\u4f53\u3092\u8c4a\u5bcc\u306b\u542b\u3080\u8840\u6db2\u88fd\u5264\u3067\u3042\u308a\u3001\u75c5\u6c17\u306e\u671f\u9593\u3092\u77ed\u7e2e\u3057\u305f\u308a\u3001\u91cd\u75c7\u5ea6\u3092\u8efd\u6e1b\u3057\u305f\u308a\u3059\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u300d\u3068FDA\u306f\u8aac\u660e\u3057\u3066\u3044\u307e\u3059[FDA Press Release, 24-March-2020]\u3002<a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/investigational-new-drug-ind-or-device-exemption-ide-process-cber\/investigational-covid-19-convalescent-plasma-emergency-inds\" target=\"_blank\" rel=\"noopener\">FDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8<\/a>\u3067\u306f\u300121 CFR 312\u306b\u8a18\u8f09\u3055\u308c\u3066\u3044\u308b\u300c\u4f1d\u7d71\u7684\u306a\u300dIND\u898f\u5236\u7d4c\u8def\u3092\u5f15\u7528\u3057\u306a\u304c\u3089\u3001\u56de\u5fa9\u671f\u8840\u6f3f\u306b\u8208\u5473\u306e\u3042\u308b\u7814\u7a76\u8005\u304c\u6cbb\u9a13\u85ac\u4f7f\u7528\u306e\u7533\u8acb\u3092\u884c\u3046\u3053\u3068\u3092\u300c\u5968\u52b1\u300d\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u91cd\u7be4\u306aCOVID-19\u611f\u67d3\u75c7\u307e\u305f\u306f\u76f4\u3061\u306b\u751f\u547d\u3092\u8105\u304b\u3059COVID-19\u611f\u67d3\u75c7\u3092\u6709\u3059\u308b\u300d\u500b\u4eba\u60a3\u8005\u306f\u3001\u533b\u5e2b\u304c\u5358\u4e00\u60a3\u8005\u7dca\u6025IND\uff08eIND\uff09\u3092\u7533\u8acb\u3059\u308c\u3070\u3001COVID-19\u306e\u56de\u5fa9\u671f\u8840\u6f3f\u3078\u306e\u62e1\u5927\u30a2\u30af\u30bb\u30b9\u3092\u6c42\u3081\u308b\u3053\u3068\u304c\u3067\u304d\u308b\u3001\u3068FDA\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8\u306f\u8ff0\u3079\u3066\u3044\u307e\u3059\u300221 CFR 312.310\u3067\u8aac\u660e\u3055\u308c\u3066\u3044\u308b\u3088\u3046\u306b\u3001\u3053\u306e\u30bf\u30a4\u30d7\u306e\u62e1\u5f35\u30a2\u30af\u30bb\u30b9\u306f\u3001&#8221;\u30e9\u30a4\u30bb\u30f3\u30b9\u3092\u53d6\u5f97\u3057\u305f\u533b\u5e2b\u306b\u3088\u308b\u500b\u3005\u306e\u60a3\u8005\u306e\u6cbb\u7642 &#8220;\u306b\u95a2\u9023\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>Scripps Research Institute\u306e\u7814\u7a76\u8005\u306f\u3001SARS-CoV-2\u306b\u611f\u67d3\u3057\u305f\u4eba\u3005\u306b\u6709\u52b9\u306a\u6cbb\u7642\u6cd5\u3068\u306a\u308a\u3046\u308b\u65e2\u5b58\u306e\u6297\u30a6\u30a4\u30eb\u30b9\u5264\u3092\u7279\u5b9a\u3059\u308b\u305f\u3081\u306b\u3001FDA\u627f\u8a8d\u85ac\u306e\u30b3\u30ec\u30af\u30b7\u30e7\u30f3\u3067\u3042\u308bReFRAME\u306b\u542b\u307e\u308c\u308b14,000\u7a2e\u985e\u4ee5\u4e0a\u306e\u5316\u5408\u7269\u3092\u691c\u8a0e\u3057\u3066\u3044\u307e\u3059\u3002Scripps Research\u306e\u4ed6\u306e\u30d7\u30ed\u30b8\u30a7\u30af\u30c8\u3067\u306f\u3001SARS-CoV-2\u306e\u8907\u88fd\u3092\u9632\u3050\u5206\u5b50\u306e\u8a55\u4fa1\u3084\u30016\u3064\u306eCOVID-19\u81e8\u5e8a\u8a66\u9a13\u3067\u7814\u7a76\u4e2d\u306eremdesivir\uff08Gilead Sciences, Inc.\u88fd\uff09\u306e\u52b9\u679c\u3092\u5411\u4e0a\u3055\u305b\u308b\u305f\u3081\u306e\u30a2\u30c9\u30aa\u30f3\u3068\u3057\u3066\u65e2\u5b58\u306e\u85ac\u5264\u3092\u4f7f\u7528\u3059\u308b\u3053\u3068\u3092\u8abf\u67fb\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u9032\u884c\u306b\u4f34\u3044\u3001COVID-19\u306e\u6cbb\u7642\u85ac\u3092\u958b\u767a\u3057\u3066\u3044\u308b\u4f01\u696d\u306f\u3001\u6cbb\u9a13\u85ac\u306e\u9700\u8981\u306e\u5897\u52a0\u306b\u76f4\u9762\u3057\u3066\u3044\u307e\u3059\u3002\u4f8b\u3048\u3070\u3001<a href=\"https:\/\/www.gilead.com\/purpose\/advancing-global-health\/covid-19\/emergency-access-to-remdesivir-outside-of-clinical-trials\" target=\"_blank\" rel=\"noopener\">Gilead\u793e\u306e\u30a6\u30a7\u30d6\u30b5\u30a4\u30c8<\/a>\u3067\u306f\u3001remdesivir\u306b\u5bfe\u3059\u308b\u300c\u5727\u5012\u7684\u306a\u9700\u8981\u300d\u306b\u3064\u3044\u3066\u8a00\u53ca\u3057\u3066\u304a\u308a\u3001\u540c\u793e\u306f\u300c\u73fe\u5728\u3001\u500b\u4eba\u304b\u3089\u306eoverwhelming demand\u306e\u4f9d\u983c\u3092\u53d7\u3051\u4ed8\u3051\u3066\u3044\u308b\u6bb5\u968e\u304b\u3089\u3001\u3088\u308a\u5e83\u7bc4\u306a\u4f7f\u7528\u306e\u305f\u3081\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u3092\u958b\u767a\u3059\u308b\u6bb5\u968e\u306b\u79fb\u884c\u3057\u3066\u3044\u308b\u300d\u3068\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<h4><strong>\u5f97\u3089\u308c\u305f\u6559\u8a13<\/strong><\/h4>\n<p>\u533b\u85ac\u54c1\u306e\u9069\u5fdc\u5916\u4f7f\u7528\u3092\u6025\u3050\u3053\u3068\u306e\u5371\u967a\u6027\u306f\u3001\u4eca\u9031\u3001\u30a2\u30ea\u30be\u30ca\u5dde\u306e\u7537\u6027\u304cSARS-CoV-2\u611f\u67d3\u304b\u3089\u8eab\u3092\u5b88\u308b\u3068\u8003\u3048\u3066\u3044\u305f\u5316\u5b66\u7269\u8cea\u3001\u30ea\u30f3\u9178\u30af\u30ed\u30ed\u30ad\u30f3\u3092\u6442\u53d6\u3057\u3066\u6b7b\u4ea1\u3057\u305f\u3053\u3068\u3067\u5287\u7684\u306b\u660e\u3089\u304b\u306b\u306a\u308a\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u533b\u7642\u7528\u30af\u30ed\u30ed\u30ad\u30f3\u306f\u3001\u51e6\u65b9\u7b8b\u85ac\u3001\u6700\u521d\u306e\u6297\u30de\u30e9\u30ea\u30a2\u85ac\u3068\u3057\u3066 1949 \u5e74\u306b FDA \u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u3053\u308c\u3068\u306f\u5225\u306e\u975e\u533b\u7642\u7528\u30af\u30ed\u30ed\u30ad\u30f3\u306f\u3001\u9b5a\u306e\u6c34\u69fd\u3092\u304d\u308c\u3044\u306b\u3059\u308b\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u308b\u88fd\u54c1\u3067\u3068\u3057\u3066\u8ca9\u58f2\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u30cb\u30e5\u30fc\u30b9\u306b\u3088\u308b\u3068\u3001\u7537\u6027\u3068\u5f7c\u306e\u59bb\u306f\u3001COVID-19\u306e\u6f5c\u5728\u7684\u306a\u6cbb\u7642\u6cd5\u3068\u3057\u3066\u3001\u305d\u306e\u52b9\u679c\u3092\u7d76\u8cdb\u3059\u308b\u30c6\u30ec\u30d3\u5831\u9053\u3092\u898b\u305f\u5f8c\u3001\u3053\u306e\u5316\u5b66\u7269\u8cea\u3092\u670d\u7528\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>\u201cThe nice part is that it\u2019s been around a long time, so we know that if\u2014if things don\u2019t go as planned, it\u2019s not going to kill anybody.\u201d<\/p>\n<p>\u30c9\u30ca\u30eb\u30c9\u30fb\u30c8\u30e9\u30f3\u30d7\u7c73\u5927\u7d71\u9818\u306f3\u670819\u65e5\u306e\u30db\u30ef\u30a4\u30c8\u30cf\u30a6\u30b9\u3067\u306e\u8a18\u8005\u4f1a\u898b\u3067\u3001\u30af\u30ed\u30ed\u30ad\u30f3\u306b\u3064\u3044\u3066\u3053\u3046\u8ff0\u3079\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19 \u306b\u95a2\u9023\u3059\u308b\u8ffd\u52a0\u306e\u66f4\u65b0\u60c5\u5831\u3084\u6700\u65b0\u30cb\u30e5\u30fc\u30b9\u306b\u3064\u3044\u3066\u306f\u3001\u5f15\u304d\u7d9a\u304d\u5f0a\u793e\u30d6\u30ed\u30b0\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3066\u304f\u3060\u3055\u3044\u3002<a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a> \u3092\u3054\u5229\u7528\u306e\u65b9\u306f\u3001\u30c7\u30b9\u30af\u30c8\u30c3\u30d7\u307e\u305f\u306f <a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a> \u306e\u30e2\u30d0\u30a4\u30eb\u30a2\u30d7\u30ea\u3067\u30a2\u30e9\u30fc\u30c8\u3092\u8a2d\u5b9a\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<p>&nbsp;<\/p>\n<p><strong><a href=\"https:\/\/clarivate.com\/cortellis\/ja\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a> \u3092\u5229\u7528\u3057\u3066\u3001\u6700\u65b0\u306e\u898f\u5236\u5909\u66f4\u3092\u628a\u63e1\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>MEG EGAN-AUDERSET Medical &amp; Regulatory Writer, Cortellis Clarivate \u82f1\u8a9e\u539f\u6587 COVID-19\u306e\u4e16\u754c\u7684\u306a\u5927\u6d41\u884c\u304c\u7d9a\u304f\u4e2d\u3001\u81e8\u5e8a\u5bb6\u3084\u653f\u6cbb\u5bb6\u306f\u3001SARS-CoV-2\u611f\u67d3\u75c7\u306e\u6cbb\u7642\u85ac\u3068\u3057\u3066\u3001\u3059\u3067\u306b\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u65e2\u77e5\u306e\u533b\u85ac\u54c1\u3092\u4f7f\u7528\u3059\u308b\u53ef\u80fd\u6027\u306b\u71b1\u5fc3\u306b\u5bfe\u5fdc\u3057\u3066\u304d\u307e\u3057\u305f\u3002\u307e\u3060 COVID-19 \u306b\u7279\u5316\u3057\u3066 FDA \u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305f\u6cbb\u7642\u6cd5\u304c\u306a\u3044\u305f\u3081\u3001\u533b\u85ac\u54c1\u306e\u9069\u5fdc\u5916\u4f7f\u7528\u306f\u8003\u3048\u308b\u307e\u3067\u3082\u306a\u3044\u3088\u3046\u306b\u601d\u3048\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002 &nbsp; \u3057\u304b\u3057\u3001\u533b\u85ac\u54c1\u306e\u9069\u5fdc\u5916\u4f7f\u7528\u306b\u306f\u30ea\u30b9\u30af\u304c\u306a\u3044\u308f\u3051\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u3042\u308b\u9069\u5fdc\u75c7\u306b\u5bfe\u3057\u3066\u5b89\u5168\u304b\u3064\u6709\u52b9\u3067\u3042\u308b\u3068\u627f\u8a8d\u3055\u308c\u305f\u5316\u5408\u7269\u306e\u591a\u304f\u306f\u3001\u5225\u306e\u9069\u5fdc\u75c7\u306b\u5bfe\u3057\u3066\u306f\u52b9\u679c\u3082\u5b89\u5168\u6027\u3082\u3042\u308a\u307e\u305b\u3093\u3002\u6cbb\u7642\u6cd5\u306e\u6f5c\u5728\u7684\u306a\u5229\u70b9\u3068\u30ea\u30b9\u30af\u3092\u79e4\u91cf\u3059\u308b\u3053\u3068\u306f\u3001FDA\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306e\u4e0d\u53ef\u6b20\u306a\u90e8\u5206\u3067\u3042\u308a\u3001FDA\u306f\u975e\u5e38\u306b\u771f\u5263\u306b\u53d6\u308a\u7d44\u3093\u3067\u3044\u307e\u3059\u3002\u4e16\u754c\u7684\u306a\u30a6\u30a4\u30eb\u30b9\u306e\u5927\u6d41\u884c\u306b\u76f4\u9762\u3057\u3066\u3082\u3001FDA\u306f\u3001\u516c\u8846\u885b\u751f\u306e\u4fdd\u8b77\u3068\u3044\u3046\u305d\u306e\u4e3b\u306a\u8cac\u4efb\u306b\u80cc\u304f\u3053\u3068\u304c\u306a\u3044\u3088\u3046\u306b\u3001\u305d\u306e\u57fa\u6e96\u3092\u4e0b\u3052\u308b\u3053\u3068\u3092\u671b\u3093\u3067\u3044\u307e\u305b\u3093\u3002 &nbsp; &nbsp; \u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306e\u9593\u306b\u6f5c\u5728\u7684\u306a\u6cbb\u7642\u6cd5\u306b\u30a2\u30af\u30bb\u30b9\u3059\u308b \u65b0\u3057\u3044\u9069\u5fdc\u75c7\u306e\u305f\u3081\u306b\u627f\u8a8d\u3055\u308c\u305f\u85ac\u3092\u518d\u5229\u7528\u3059\u308b\u3053\u3068\u306f\u3001\u78ba\u304b\u306b\u300c\u6cbb\u7642\u6cd5\u306e\u9078\u629e\u80a2\u304c\u307b\u3068\u3093\u3069\u306a\u3044\u3001\u307e\u305f\u306f\u306a\u3044\u75c5\u6c17\u3084\u6761\u4ef6\u306e\u6cbb\u7642\u306e\u305f\u3081\u306e\u52b9\u7387\u7684\u306a\u533b\u85ac\u54c1\u958b\u767a\u306e\u9053\u7b4b\u300d\u3067\u3042\u308b\u304b\u3082\u3057\u308c\u306a\u3044\u3001\u3068FDA\u306f\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u540c\u6a5f\u95a2\u306f2019\u5e7412\u6708\u306b\u3001\u9069\u5fdc\u5916\u4f7f\u7528\u306e\u53ef\u80fd\u6027\u3092\u63a2\u308b\u305f\u3081\u306e2\u65e5\u9593\u306e\u516c\u958b\u4f1a\u8b70\u3092\u5171\u50ac\u3057\u307e\u3057\u305f[FDA Workshop Bulletin: Addressing Obstacles to Repurposing Off-Patent Drugs, 05\/06-December-2019]\u3002 &nbsp;&#8230;<\/p>\n","protected":false},"author":61,"featured_media":1779,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_links_to":"","_links_to_type":0,"footnotes":""},"categories":[1228],"tags":[],"class_list":["post-1778","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-life-sciences-healthcare"],"acf":[],"lang":"ja","translations":{"ja":1778},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1778","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/users\/61"}],"replies":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/comments?post=1778"}],"version-history":[{"count":0,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/posts\/1778\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media\/1779"}],"wp:attachment":[{"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/media?parent=1778"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/categories?post=1778"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/clarivate.com\/life-sciences-healthcare\/wp-json\/wp\/v2\/tags?post=1778"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}