{"id":8660,"date":"2022-05-03T12:59:33","date_gmt":"2022-05-03T16:59:33","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/what-does-fda-approved-really-mean\/"},"modified":"2022-08-18T21:16:04","modified_gmt":"2022-08-19T01:16:04","slug":"fda%e6%89%bf%e8%aa%8d%e6%b8%88%e3%81%bf%e3%81%ae%e6%9c%ac%e5%bd%93%e3%81%ae%e6%84%8f%e5%91%b3%e3%81%a8%e3%81%af","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/ja\/article\/fda%e6%89%bf%e8%aa%8d%e6%b8%88%e3%81%bf%e3%81%ae%e6%9c%ac%e5%bd%93%e3%81%ae%e6%84%8f%e5%91%b3%e3%81%a8%e3%81%af\/","title":{"rendered":"\u300cFDA\u627f\u8a8d\u6e08\u307f\u300d\u3068\u306f\u3069\u3046\u3044\u3046\u610f\u5473\u3067\u3059\u304b?"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">\u88fd\u54c1\u306b\u300cFDA\u627f\u8a8d\u6e08\u307f\u300d\u3068\u3044\u3046\u7528\u8a9e\u304c\u8868\u793a\u3055\u308c\u3066\u3044\u308b\u5834\u5408\u3001\u653f\u5e9c\u6a5f\u95a2\u306b\u3088\u3063\u3066\u5b89\u5168\u3067\u52b9\u679c\u7684\u3067\u3042\u308b\u3053\u3068\u304c\u691c\u8a3c\u3055\u308c\u3066\u3044\u308b\u3068\u8003\u3048\u308b\u306e\u306f\u7c21\u5358\u3067\u3059. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3057\u304b\u3057\u3001\u305d\u308c\u306f\u672c\u5f53\u306b\u3069\u3046\u3044\u3046\u610f\u5473\u3067\u3059\u304b\uff1f<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3053\u306e\u8a18\u4e8b\u3067\u306f\u3001\u300cFDA \u627f\u8a8d\u6e08\u307f\u300d\u306e\u5b9f\u969b\u306e\u610f\u5473\u3068\u3001\u88fd\u54c1\u3001\u7279\u306b\u533b\u85ac\u54c1\u3001FDA \u627f\u8a8d\u3092\u53d6\u5f97\u3059\u308b\u30d7\u30ed\u30bb\u30b9\u306b\u3064\u3044\u3066\u8aac\u660e\u3057\u307e\u3059\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30d7\u30ed\u30bb\u30b9\u3068\u300cFDA \u627f\u8a8d\u6e08\u307f\u300d\u304c\u5b9f\u969b\u306b\u4f55\u3092\u610f\u5473\u3059\u308b\u304b\u3092\u7406\u89e3\u3059\u308b\u3053\u3068\u306f\u3001FDA \u627f\u8a8d\u88fd\u54c1\u306b\u3088\u3063\u3066\u88ab\u5bb3\u3092\u53d7\u3051\u305f\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u306e\u306b\u5f79\u7acb\u3061\u307e\u3059\u3002<\/span><\/p>\n<h2><b>\u533b\u85ac\u54c1\u306f\u3069\u306e\u3088\u3046\u306b\u3057\u3066 FDA \u306e\u627f\u8a8d\u3092\u5f97\u308b\u306e\u3067\u3059\u304b?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">\u533b\u85ac\u54c1\u304c\u7c73\u56fd\u3067\u8ca9\u58f2\u3055\u308c\u308b\u524d\u306b\u3001FDA \u306b\u3088\u308b\u53b3\u683c\u306a\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u3092\u7d4c\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 FDA \u306b\u306f\u3001\u533b\u85ac\u54c1\u304c\u627f\u8a8d\u3055\u308c\u308b\u524d\u306b\u6e80\u305f\u3055\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u591a\u304f\u306e\u8981\u4ef6\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u85ac\u306f\u5b89\u5168\u3067\u52b9\u679c\u7684\u3067\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u85ac\u306f\u9069\u6b63\u88fd\u9020\u57fa\u6e96 (GMP) \u306b\u5f93\u3063\u3066\u88fd\u9020\u3055\u308c\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002 GMP\u306f\u3001\u533b\u85ac\u54c1\u304c\u5b89\u5168\u304b\u3064\u54c1\u8cea\u57fa\u6e96\u306b\u5f93\u3063\u3066\u88fd\u9020\u3055\u308c\u308b\u3053\u3068\u3092\u4fdd\u8a3c\u3059\u308b\u4e00\u9023\u306e\u898f\u5236\u3067\u3059\u3002<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u85ac\u306b\u306f\u9069\u5207\u306a\u30e9\u30d9\u30eb\u304c\u4ed8\u3051\u3089\u308c\u3066\u3044\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002\u30e9\u30d9\u30eb\u306b\u306f\u3001\u85ac\u306e\u540d\u524d\u3001\u6295\u4e0e\u91cf\u3001\u4f7f\u7528\u65b9\u6cd5\u3092\u8a18\u8f09\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002\u30e9\u30d9\u30eb\u306f\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3068\u526f\u4f5c\u7528\u306b\u3064\u3044\u3066\u3082\u8b66\u544a\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u85ac\u306b\u306f\u60a3\u8005\u6dfb\u4ed8\u6587\u66f8 (PPI) \u304c\u6dfb\u4ed8\u3055\u308c\u3066\u3044\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 PPI \u306f\u3001\u60a3\u8005\u306b\u85ac\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092\u63d0\u4f9b\u3059\u308b\u6587\u66f8\u3067\u3059\u3002\u85ac\u306e\u7528\u9014\u3001\u6f5c\u5728\u7684\u306a\u30ea\u30b9\u30af\u3001\u526f\u4f5c\u7528\u3001\u670d\u7528\u65b9\u6cd5\u306b\u95a2\u3059\u308b\u60c5\u5831\u304c\u542b\u307e\u308c\u3066\u3044\u307e\u3059\u3002<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">\u65b0\u85ac\u3092\u4e0a\u5e02\u3059\u308b\u524d\u306b\u3001\u88fd\u9020\u696d\u8005\u306f\u6cbb\u9a13\u7528\u65b0\u85ac\u7533\u8acb (IND) \u3092 FDA \u306b\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">IND \u306f\u3001\u65b0\u85ac\u3092\u30d2\u30c8\u3067\u8a66\u9a13\u3059\u308b\u8a31\u53ef\u3092\u6c42\u3081\u308b\u8981\u6c42\u3067\u3059\u3002 FDA \u306f\u7533\u8acb\u66f8\u3092\u5be9\u67fb\u3057\u3001\u3055\u3089\u306b\u8a73\u3057\u3044\u60c5\u5831\u3092\u6c42\u3081\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA \u304c\u88fd\u9020\u696d\u8005\u306b\u85ac\u306e\u8a66\u9a13\u3092\u8a31\u53ef\u3059\u308b\u3053\u3068\u306b\u540c\u610f\u3057\u305f\u5834\u5408\u3001\u85ac\u306f\u3044\u308f\u3086\u308b\u81e8\u5e8a\u4fdd\u7559\u306b\u7f6e\u304b\u308c\u307e\u3059\u3002\u81e8\u5e8a\u4fdd\u7559\u3068\u306f\u3001FDA \u304c\u5b89\u5168\u4e0a\u306e\u61f8\u5ff5\u304b\u3089\u81e8\u5e8a\u8a66\u9a13\u3092\u4e2d\u6b62\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u88fd\u9020\u696d\u8005\u306f\u3001\u65b0\u85ac\u7533\u8acb (NDA) \u3092 FDA \u306b\u63d0\u51fa\u3059\u308b\u5fc5\u8981\u3082\u3042\u308a\u307e\u3059\u3002 NDA \u306f\u3001\u524d\u81e8\u5e8a\u8a66\u9a13\u304a\u3088\u3073\u81e8\u5e8a\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u3092\u542b\u3080\u3001\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u5305\u62ec\u7684\u306a\u30ec\u30dd\u30fc\u30c8\u3067\u3059\u3002 FDA \u306f NDA \u3092\u5be9\u67fb\u3057\u3001\u8a73\u7d30\u60c5\u5831\u3092\u6c42\u3081\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA \u304c\u88fd\u9020\u696d\u8005\u306b\u85ac\u306e\u8ca9\u58f2\u3092\u8a31\u53ef\u3059\u308b\u3053\u3068\u306b\u540c\u610f\u3057\u305f\u5834\u5408\u3001\u6700\u7d42\u627f\u8a8d\u4fdd\u7559\u3068\u547c\u3070\u308c\u308b\u3082\u306e\u306b\u7f6e\u304b\u308c\u307e\u3059\u3002\u6700\u7d42\u627f\u8a8d\u4fdd\u7559\u3068\u306f\u3001FDA \u304c\u5b89\u5168\u4e0a\u306e\u61f8\u5ff5\u304b\u3089\u533b\u85ac\u54c1\u306e\u8ca9\u58f2\u3092\u505c\u6b62\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u65b0\u85ac\u306e\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u306b\u306f\u4f55\u5e74\u3082\u304b\u304b\u308b\u3053\u3068\u304c\u3042\u308a\u307e\u3059\u3002 FDA \u306f\u3001\u627f\u8a8d\u30d7\u30ed\u30bb\u30b9\u4e2d\u3044\u3064\u3067\u3082\u88fd\u9020\u696d\u8005\u306b\u8a73\u7d30\u306a\u60c5\u5831\u3092\u8981\u6c42\u3059\u308b\u5834\u5408\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<h2><b>\u300cFDA\u627f\u8a8d\u6e08\u307f\u300d\u3068\u306f\u4f55\u3092\u610f\u5473\u3057\u307e\u3059\u304b?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">\u7528\u8a9e &quot;<\/span><a href=\"https:\/\/www.fda.gov\/consumers\/consumer-updates\/it-really-fda-approved\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA\u627f\u8a8d\u6e08\u307f<\/span><\/a><span style=\"font-weight: 400;\">\u300d\u306f\u3001\u98df\u54c1\u533b\u85ac\u54c1\u5c40 (FDA) \u306b\u3088\u3063\u3066\u627f\u8a8d\u3055\u308c\u305f\u88fd\u54c1\u3092\u8868\u3059\u305f\u3081\u306b\u4f7f\u7528\u3055\u308c\u307e\u3059\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u3057\u304b\u3057\u3001\u305d\u308c\u306f\u3069\u3046\u3044\u3046\u610f\u5473\u3067\u3059\u304b\uff1f\u307b\u3068\u3093\u3069\u306e\u5834\u5408\u3001\u88fd\u9020\u696d\u8005\u304c\u88fd\u54c1\u306b\u95a2\u3059\u308b\u60c5\u5831\u3092 FDA \u306b\u63d0\u51fa\u3057\u3001\u8ca9\u58f2\u306e\u627f\u8a8d\u3092\u5f97\u305f\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002 <\/span><\/p>\n<p><b>FDA \u306f\u5b9f\u969b\u306b\u88fd\u54c1\u81ea\u4f53\u3092\u30c6\u30b9\u30c8\u3057\u3066\u3044\u307e\u305b\u3093\u3002\u30e1\u30fc\u30ab\u30fc\u304c\u63d0\u4f9b\u3059\u308b\u30c7\u30fc\u30bf\u306b\u4f9d\u5b58\u3057\u3066\u3044\u307e\u3059\u3002<\/b><\/p>\n<h2><b>FDA \u627f\u8a8d\u306e\u88fd\u54c1\u306b\u3088\u3063\u3066\u5bb3\u3092\u53d7\u3051\u305f\u5834\u5408\u306f\u3069\u3046\u306a\u308a\u307e\u3059\u304b?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">FDA \u627f\u8a8d\u306e\u88fd\u54c1\u306b\u3088\u3063\u3066\u88ab\u5bb3\u3092\u53d7\u3051\u305f\u5834\u5408\u3001\u6b21\u306e\u3053\u3068\u304c\u3067\u304d\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span><a href=\"\/ja\/%e7%b7%b4%e7%bf%92%e5%a0%b4\/%e8%a3%bd%e8%96%ac%e8%a8%b4%e8%a8%9f\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"> \u8a34\u8a1f\u3092\u8d77\u3053\u3059<\/span><\/a><span style=\"font-weight: 400;\"> \u30e1\u30fc\u30ab\u30fc\u53cd\u5bfe\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA \u306b\u306f\u3001\u533b\u85ac\u54c1\u3092\u8ca9\u58f2\u3059\u308b\u524d\u306b\u9075\u5b88\u3057\u306a\u3051\u308c\u3070\u306a\u3089\u306a\u3044\u591a\u304f\u306e\u5b89\u5168\u898f\u5236\u304c\u3042\u308a\u3001\u88fd\u9020\u696d\u8005\u306f\u3053\u308c\u3089\u306e\u898f\u5236\u3092\u9806\u5b88\u3059\u308b\u8cac\u4efb\u304c\u3042\u308a\u307e\u3059\u3002 <\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u305d\u3046\u3057\u306a\u3044\u3068\u3001\u88fd\u54c1\u306b\u3088\u3063\u3066\u5f15\u304d\u8d77\u3053\u3055\u308c\u305f\u602a\u6211\u306b\u5bfe\u3057\u3066\u8cac\u4efb\u3092\u8ca0\u3046\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u30e1\u30fc\u30ab\u30fc\u304c\u865a\u507d\u306e\u4e3b\u5f35\u3092\u3057\u305f\u304b\u3001\u85ac\u3092\u670d\u7528\u3059\u308b\u305f\u3081\u306e\u9069\u5207\u306a\u6307\u793a\u304c\u4e0e\u3048\u3089\u308c\u306a\u304b\u3063\u305f\u304b\u306b\u3088\u3063\u3066\u3001\u7570\u306a\u308b\u5f53\u4e8b\u8005\u304c\u8cac\u4efb\u3092\u8ca0\u3046\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059.<\/span><\/p>\n<h2><b>\u30ca\u30dd\u30ea\u30fb\u30b7\u30e5\u30b3\u30eb\u30cb\u30af\u306b\u9023\u7d61\u3059\u308b<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">FDA \u304c\u627f\u8a8d\u3057\u305f\u88fd\u54c1\u306b\u3088\u3063\u3066\u88ab\u5bb3\u3092\u53d7\u3051\u305f\u5834\u5408\u306f\u3001\u8a34\u8a1f\u304c\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u65ad\u3059\u308b\u306e\u306b\u5f79\u7acb\u3064\u5f01\u8b77\u58eb\u306b\u76f8\u8ac7\u3059\u308b\u3053\u3068\u304c\u91cd\u8981\u3067\u3059\u3002 <\/span><a href=\"\/ja\/%e3%81%8a%e5%95%8f%e3%81%84%e5%90%88%e3%82%8f%e3%81%9b\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Napoli Shkolnik \u306e\u30c1\u30fc\u30e0\u306b\u9023\u7d61\u3059\u308b<\/span><\/a><span style=\"font-weight: 400;\"> 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