{"id":1783,"date":"2020-04-03T11:24:40","date_gmt":"2020-04-03T02:24:40","guid":{"rendered":"https:\/\/clarivate.com\/jp\/blog\/fda%e3%80%81covid-19%e3%81%ab%e9%96%a2%e9%80%a3%e3%81%99%e3%82%8b%e3%82%ac%e3%82%a4%e3%83%80%e3%83%b3%e3%82%b9%e6%96%87%e6%9b%b8%e3%81%ae%e5%85%ac%e9%96%8b%e3%82%92%e8%bf%85%e9%80%9f%e5%8c%96\/?lang=ja"},"modified":"2020-04-03T11:24:40","modified_gmt":"2020-04-03T02:24:40","slug":"fda-to-expedite-public-release-of-guidance-documents-related-to-covid-19-2","status":"publish","type":"post","link":"https:\/\/clarivate.com\/life-sciences-healthcare\/ja\/blog\/fda-to-expedite-public-release-of-guidance-documents-related-to-covid-19-2\/","title":{"rendered":"FDA\u3001COVID-19\u306b\u95a2\u9023\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306e\u516c\u958b\u3092\u8fc5\u901f\u5316"},"content":{"rendered":"<p><strong>MEG EGAN-AUDERSET<\/strong><br \/>\nMedical &amp; Regulatory Writer, Cortellis<br \/>\nClarivate<\/p>\n<p>&nbsp;<br \/>\n<a href=\"https:\/\/clarivate.com\/cortellis\/blog\/fda-to-expedite-public-release-of-guidance-documents-related-to-covid-19\/\">\u82f1\u8a9e\u539f\u6587<\/a><\/p>\n<p>&nbsp;<br \/>\nFDA\u306f\u3001COVID-19\u95a2\u9023\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u4e00\u822c\u306b\u516c\u958b\u3059\u308b\u305f\u3081\u306e\u8fc5\u901f\u306a\u30d7\u30ed\u30bb\u30b9\u3092\u767a\u8868\u3057\u307e\u3057\u305f\uff08Federal Register, 25-March-2020\uff09\u3002\u305d\u306e\u610f\u56f3\u306f\u3001\u300cCOVID-19\u306b\u95a2\u9023\u3059\u308b\u91cd\u8981\u306a\u6a5f\u95a2\u306e\u52e7\u544a\u3084\u65b9\u91dd\u3092\u3001\u696d\u754c\u3001FDA\u30b9\u30bf\u30c3\u30d5\u3001\u305d\u306e\u4ed6\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u306b\u8fc5\u901f\u306b\u666e\u53ca\u3055\u305b\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u300d\u3067\u3042\u308b\u3068\u3001FDA\u306f\u30d5\u30a7\u30c7\u30e9\u30eb\u30fb\u30ec\u30b8\u30b9\u30bf\u306e\u767a\u8868\u3067\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\uff08\u6ce8: \u30d7\u30ed\u30bb\u30b9\u306f COVID-19 \u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306b\u95a2\u9023\u3059\u308b FDA \u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u56fa\u6709\u306e\u3082\u306e\u3067\u3042\u308a\u3001\u305d\u308c\u306f\u4ed6\u306e FDA \u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u306f\u62e1\u5f35\u3055\u308c\u307e\u305b\u3093\u3002\uff09<\/p>\n<p>&nbsp;<\/p>\n<ul>\n<li>\u8fc5\u901f\u304b\u3064\u52b9\u7387\u7684\u306b\u884c\u52d5\u3059\u308b\u5fc5\u8981\u6027\u306e\u305f\u3081\u306b\u3001FDA\u306f\u300canticipates\u300d\u3068\u3057\u4e8b\u524d\u306e\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u306a\u3057\u3067COVID-19\u95a2\u9023\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u767a\u884c\u3057\u307e\u3059\u3002<\/li>\n<li>FDA\u306f\u307e\u3060\u300c\u30b3\u30e1\u30f3\u30c8\u3092\u52df\u96c6\u3057\u3001\u53d7\u3051\u53d6\u3063\u305f\u3059\u3079\u3066\u306e\u30b3\u30e1\u30f3\u30c8\u3092\u78ba\u8a8d\u3057\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u9069\u5b9c\u4fee\u6b63\u3059\u308b\u300d\u3068\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u767a\u884c\u524d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5404\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u306f\u3001\u30b3\u30e1\u30f3\u30c8\u3092\u63d0\u51fa\u3059\u308b\u305f\u3081\u306edocket\u756a\u53f7\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>COVID-19\u306b\u95a2\u9023\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306f\u3001FDA\u306e\u30a6\u30a7\u30d6\u30da\u30fc\u30b8\u304b\u3089\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\uff1a&#8221;<a href=\"https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-issues\/coronavirus-disease-2019-covid-19\/\" target=\"_blank\" rel=\"noopener\">Coronavirus Disease 2019 (COVID-19)<\/a>.&#8221; \u3053\u308c\u3089\u306f\u307e\u305f\u3001FDA\u306e &#8220;<a href=\"https:\/\/www.fda.gov\/emergency-preparedness-and-response\/mcm-issues\/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders\/\" target=\"_blank\" rel=\"noopener\">COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders<\/a>&#8220;\u30b5\u30a4\u30c8\u3084&#8221;<a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/\" target=\"_blank\" rel=\"noopener\">Search for FDA Guidance Documents<\/a>\u201d\u304b\u3089\u3082\u30a2\u30af\u30bb\u30b9\u53ef\u80fd\u3067\u3059\u3002<\/li>\n<li>FDA\u306f\u3001\u5404\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u500b\u5225\u306e\u901a\u77e5\uff08NOA\uff09\u3092\u767a\u884c\u3059\u308b\u306e\u3067\u306f\u306a\u304f\u3001COVID-19\u306b\u95a2\u9023\u3059\u308b\u69d8\u3005\u306a\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306e\u7d71\u5408NOA\u3092\u5b9a\u671f\u7684\u306b\u767a\u884c\u3057\u307e\u3059\u3002\u7d71\u5408NOA\u306b\u306f\u3001\u30b3\u30e1\u30f3\u30c8\u306e\u63d0\u51fa\u65b9\u6cd5\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/li>\n<li>FDA\u306f\u3001COVID-19\u306b\u95a2\u9023\u3057\u305f\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u767a\u884c\u3059\u308b\u53ef\u80fd\u6027\u306e\u3042\u308b\u5404\u6a5f\u95a2\u306e\u30bb\u30f3\u30bf\u30fc\u3084\u30aa\u30d5\u30a3\u30b9\u3054\u3068\u306b\u500b\u5225\u306edocket\u756a\u53f7\u3092\u8a2d\u3051\u308b\u4e88\u5b9a\u3067\u3059\u3002\u88681\u306f\u3001FDA\u306e\u30bb\u30f3\u30bf\u30fc\/\u30aa\u30d5\u30a3\u30b9\u3068\u305d\u306edocket\u756a\u53f7\u3092\u793a\u3057\u3066\u3044\u307e\u3059\u3002<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<table class=\"table table-sm\">\n<tbody>\n<tr>\n<td width=\"456\"><strong>Docket title for each FDA center or office<\/strong><\/td>\n<td width=\"162\"><strong>Docket number<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"456\">Center for Drug Evaluation and Research (CDER) COVID-19<\/td>\n<td width=\"162\">FDA-2020-D-1136<\/td>\n<\/tr>\n<tr>\n<td width=\"456\">Center for Biologics Evaluation and Research (CBER) COVID-19<\/td>\n<td width=\"162\">FDA-2020-D-1137<\/td>\n<\/tr>\n<tr>\n<td width=\"456\">Center for Devices and Radiological Health (CDRH) COVID-19<\/td>\n<td width=\"162\">FDA-2020-D-1138<\/td>\n<\/tr>\n<tr>\n<td width=\"456\">Center for Food Safety and Applied Nutrition (CFSAN) COVID-19<\/td>\n<td width=\"162\">FDA-2020-D-1139<\/td>\n<\/tr>\n<tr>\n<td width=\"456\">Center for Veterinary Medicine (CVM) COVID-19<\/td>\n<td width=\"162\">FDA-2020-D-1140<\/td>\n<\/tr>\n<tr>\n<td width=\"456\">Center for Tobacco Products (CTP) COVID-19<\/td>\n<td width=\"162\">FDA-2020-D-1141<\/td>\n<\/tr>\n<tr>\n<td width=\"456\">Office of the Commissioner (OC) COVID-19<\/td>\n<td width=\"162\">FDA-2020-D-1142<\/td>\n<\/tr>\n<tr>\n<td width=\"456\">Office of Regulatory Affairs (ORA) COVID-19<\/td>\n<td width=\"162\">FDA-2020-D-1143<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>\u88681. FDA COVID-19\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u5bfe\u3059\u308b\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u306e\u305f\u3081\u306edocket\u756a\u53f7<\/p>\n<p>&nbsp;<\/p>\n<p>21 CFR 10.115\u300c<em>Good guidance practices<\/em>\u300d\u306b\u306f\u3001FDA\u304c\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u4f5c\u6210\u30fb\u767a\u884c\u3059\u308b\u969b\u306b\u5f93\u3046\u4e00\u822c\u7684\u306a\u30d7\u30ed\u30bb\u30b9\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002<\/p>\n<p>FDA\u306f2\u670829\u65e5\u306b<a href=\"https:\/\/clarivate.com\/cortellis\/blog\/covid-19-testing-fda-guidance-update\/\">\u6700\u521d\u306eCOVID-19\u306b\u7279\u5316\u3057\u305f\u30ac\u30a4\u30c0\u30f3\u30b9<\/a>\u3092\u516c\u958b\u3057\u3001\u305d\u306e\u5f8c\u30013\u670816\u65e5\u306b\u66f4\u65b0\u7248\u300c<em>Policy for Diagnostic Tests for Coronavirus Diseases2019 during the Public Health Emergency<\/em>\u300d\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002\u3053\u308c\u306f\u5373\u65e5\u65bd\u884c\u3055\u308c\u307e\u3057\u305f\u3002FDA\u306f\u305d\u306e\u5f8c\u3001SARS-CoV-2\u306e\u691c\u67fb\u3092\u958b\u767a\u3057\u3066\u3044\u308b\u3001\u307e\u305f\u306f\u958b\u767a\u3057\u305f\u3053\u3068\u306e\u3042\u308b\u81e8\u5e8a\u691c\u67fb\u65bd\u8a2d\u3084\u30e1\u30fc\u30ab\u30fc\u3068\u306e\u9023\u643a\u3092\u56f3\u308b\u305f\u3081\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u306b\u95a2\u3059\u308b\u516c\u958b\u30ef\u30fc\u30af\u30b7\u30e7\u30c3\u30d7\u3092\u958b\u50ac\u3057\u307e\u3057\u305f\u3002FDA\u306f3\u670814\u65e5\u304b\u30893\u670826\u65e5\u307e\u3067\u306e\u9593\u306b\u3001\u81e8\u5e8a\u8a66\u9a13\u306e\u5b9f\u65bd\u3084\u6709\u5bb3\u4e8b\u8c61\u306e\u5831\u544a\u304b\u3089\u4eba\u5de5\u547c\u5438\u5668\u3084\u30a2\u30eb\u30b3\u30fc\u30eb\u30d9\u30fc\u30b9\u306e\u624b\u6307\u6d88\u6bd2\u5264\u306b\u81f3\u308b\u300113\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u95a2\u9023\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u767a\u884c\u3057\u307e\u3057\u305f\u3002<\/p>\n<p>&nbsp;<\/p>\n<p>COVID-19 \u306b\u95a2\u3059\u308b\u8ffd\u52a0\u60c5\u5831\u3084\u6700\u65b0\u30cb\u30e5\u30fc\u30b9\u306b\u3064\u3044\u3066\u306f\u3001\u5f15\u304d\u7d9a\u304d\u5f0a\u793e\u30d6\u30ed\u30b0\u8a18\u4e8b\u3092\u30c1\u30a7\u30c3\u30af\u3057\u3066\u304f\u3060\u3055\u3044\u3002<a href=\"https:\/\/clarivate.com\/cortellis\/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\/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\/solutions\/regulatory-intelligence-solutions\/\">Cortellis Regulatory Intelligence<\/a> \u3092\u5229\u7528\u3059\u308b\u3053\u3068\u3067\u3001\u6700\u65b0\u306e\u898f\u5236\u5909\u66f4\u3092\u5e38\u306b\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 &nbsp; \u82f1\u8a9e\u539f\u6587 &nbsp; FDA\u306f\u3001COVID-19\u95a2\u9023\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u4e00\u822c\u306b\u516c\u958b\u3059\u308b\u305f\u3081\u306e\u8fc5\u901f\u306a\u30d7\u30ed\u30bb\u30b9\u3092\u767a\u8868\u3057\u307e\u3057\u305f\uff08Federal Register, 25-March-2020\uff09\u3002\u305d\u306e\u610f\u56f3\u306f\u3001\u300cCOVID-19\u306b\u95a2\u9023\u3059\u308b\u91cd\u8981\u306a\u6a5f\u95a2\u306e\u52e7\u544a\u3084\u65b9\u91dd\u3092\u3001\u696d\u754c\u3001FDA\u30b9\u30bf\u30c3\u30d5\u3001\u305d\u306e\u4ed6\u306e\u5229\u5bb3\u95a2\u4fc2\u8005\u306b\u8fc5\u901f\u306b\u666e\u53ca\u3055\u305b\u308b\u3053\u3068\u3092\u53ef\u80fd\u306b\u3059\u308b\u3053\u3068\u300d\u3067\u3042\u308b\u3068\u3001FDA\u306f\u30d5\u30a7\u30c7\u30e9\u30eb\u30fb\u30ec\u30b8\u30b9\u30bf\u306e\u767a\u8868\u3067\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\uff08\u6ce8: \u30d7\u30ed\u30bb\u30b9\u306f COVID-19 \u516c\u8846\u885b\u751f\u4e0a\u306e\u7dca\u6025\u4e8b\u614b\u306b\u95a2\u9023\u3059\u308b FDA \u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u56fa\u6709\u306e\u3082\u306e\u3067\u3042\u308a\u3001\u305d\u308c\u306f\u4ed6\u306e FDA \u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u306f\u62e1\u5f35\u3055\u308c\u307e\u305b\u3093\u3002\uff09 &nbsp; \u8fc5\u901f\u304b\u3064\u52b9\u7387\u7684\u306b\u884c\u52d5\u3059\u308b\u5fc5\u8981\u6027\u306e\u305f\u3081\u306b\u3001FDA\u306f\u300canticipates\u300d\u3068\u3057\u4e8b\u524d\u306e\u30d1\u30d6\u30ea\u30c3\u30af\u30b3\u30e1\u30f3\u30c8\u306a\u3057\u3067COVID-19\u95a2\u9023\u306e\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u767a\u884c\u3057\u307e\u3059\u3002 FDA\u306f\u307e\u3060\u300c\u30b3\u30e1\u30f3\u30c8\u3092\u52df\u96c6\u3057\u3001\u53d7\u3051\u53d6\u3063\u305f\u3059\u3079\u3066\u306e\u30b3\u30e1\u30f3\u30c8\u3092\u78ba\u8a8d\u3057\u3001\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u3092\u9069\u5b9c\u4fee\u6b63\u3059\u308b\u300d\u3068\u3057\u3066\u3044\u307e\u3059\u304c\u3001\u767a\u884c\u524d\u3067\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u5404\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306b\u306f\u3001\u30b3\u30e1\u30f3\u30c8\u3092\u63d0\u51fa\u3059\u308b\u305f\u3081\u306edocket\u756a\u53f7\u304c\u8a18\u8f09\u3055\u308c\u3066\u3044\u307e\u3059\u3002 COVID-19\u306b\u95a2\u9023\u3059\u308b\u30ac\u30a4\u30c0\u30f3\u30b9\u6587\u66f8\u306f\u3001FDA\u306e\u30a6\u30a7\u30d6\u30da\u30fc\u30b8\u304b\u3089\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u30a2\u30af\u30bb\u30b9\u3067\u304d\u308b\u3088\u3046\u306b\u306a\u308a\u307e\u3059\uff1a&#8221;Coronavirus Disease 2019 (COVID-19).&#8221; 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