{"id":237601,"date":"2023-04-02T08:33:49","date_gmt":"2023-04-02T15:33:49","guid":{"rendered":"https:\/\/newsforchinese.com\/v3\/?p=237601"},"modified":"2023-04-02T08:33:51","modified_gmt":"2023-04-02T15:33:51","slug":"fda%e6%89%b9%e5%87%86%e7%b4%8d%e6%b4%9b%e9%85%ae%e6%ab%83%e6%aa%af%e9%8a%b7%e5%94%ae","status":"publish","type":"post","link":"https:\/\/newsforchinese.com\/v3\/2023\/04\/02\/fda%e6%89%b9%e5%87%86%e7%b4%8d%e6%b4%9b%e9%85%ae%e6%ab%83%e6%aa%af%e9%8a%b7%e5%94%ae\/","title":{"rendered":"FDA\u6279\u51c6\u7d0d\u6d1b\u916e\u6ac3\u6aaf\u92b7\u552e"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">U.S. Food and Drug Administration\u9031\u4e09\u6279\u51c6\u5728\u6c92\u6709\u8655\u65b9\u60c5\u6cc1\u4e0b\u92b7\u552e\u7d0d\u6d1b\u916e\uff08naloxone\uff09\uff0c\u9019\u7a2e\u85e5\u7269\u56e0\u6b64\u5373\u5c07\u6210\u70ba\u7b2c\u4e00\u7a2e\u6ac3\u6aaf\u92b7\u552e\u7684\u963f\u7247\u6cbb\u7642\u85e5\u7269\u3002<\/p>\n\n\n\n<!--more-->\n\n\n\n<p 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Inc.\u5df2\u5411FDA\u63d0\u4ea4\u4e00\u4efd\u7533\u8acb\uff0c\u8acb\u6c42\u5728\u6c92\u6709\u8655\u65b9\u60c5\u6cc1\u4e0b\u5206\u92b7\u5b83\u7684\u7d0d\u7d61\u916e\u5674\u9727\u5291\u3002<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>\u7d0d\u6d1b\u916e\u73fe\u5728\u662f\u5982\u4f55\u5206\u92b7\u7684\uff1f<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">\u5373\u4f7f\u5728FDA\u6700\u65b0\u6279\u51c6\u4e4b\u524d\uff0c\u85e5\u5e97\u5c31\u53ef\u5728\u6c92\u6709\u8655\u65b9\u7684\u60c5\u6cc1\u4e0b\u92b7\u552e\u7d0d\u6d1b\u916e\uff0c\u56e0\u70ba\u6bcf\u500b\u5dde\u7684\u5b98\u54e1\u90fd\u5141\u8a31\u9019\u6a23\u505a\u3002<\/p>\n\n\n\n<p 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Simkins\u8868\u793a\uff0c\u5979\u7684\u7d44\u7e54\u5c07\u7e7c\u7e8c\u5206\u767c\u53ef\u6ce8\u5c04\u7d0d\u6d1b\u916e\u3002\u8a72\u7d44\u7e54\u53bb\u5e74\u6210\u7acb\uff0c\u65e8\u5728\u5411\u793e\u5340\u7d44\u7e54\u63d0\u4f9b\u4f4e\u6210\u672c\u3001\u6709\u6642\u662f\u514d\u8cbb\u7684\u7d0d\u6d1b\u916e\u3002 \u6ac3\u6aaf\u92b7\u552e\u6709\u7f3a\u9ede\u55ce\uff1f Stanford\u5927\u5b78\u6210\u766e\u5c08\u5bb6Keith Humphreys\u8aaa\uff0c\u4e00\u500b\u4ee4\u4eba\u64d4\u6182\u7684\u554f\u984c\u662f\uff1a\u8cfc\u8cb7Narcan\u975e\u8655\u65b9\u85e5\u7684\u4eba\u662f\u5426\u77e5\u9053\u5982\u4f55\u6b63\u78ba\u4f7f\u7528\u5b83\uff0c\u5118\u7ba1\u88fd\u9020\u5546\u8ca0\u8cac\u63d0\u4f9b\u9019\u65b9\u9762\u7684\u660e\u78ba\u8aaa\u660e\u548c\u7dda\u4e0a\u8996\u983b\u3002 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BioSolutions\u8868\u793a\uff0cNarcan\u5c07\u65bc\u590f\u672b\u5728\u975e\u8655\u65b9\u85e5\u5e02\u5834\u4e0a\u5e02\u3002 \u5176\u4ed6\u54c1\u724c\u7d0d\u6d1b\u916e\u548c\u6ce8\u5c04\u5f62\u5f0f\u5c46\u6642\u9084\u4e0d\u6703\u5728\u6ac3\u6aaf\u51fa\u552e\uff0c\u4f46\u96e2\u4e0a\u5e02\u6642\u9593\u4e0d\u6703\u592a\u4e45\u3002 \u5f97\u5230OxyContin\u88fd\u9020\u5546Purdue Pharma\u8cc7\u52a9\u7684\u975e\u71df\u5229Harm Reduction Therapeutics Inc.\u5df2\u5411FDA\u63d0\u4ea4\u4e00\u4efd\u7533\u8acb\uff0c\u8acb\u6c42\u5728\u6c92\u6709\u8655\u65b9\u60c5\u6cc1\u4e0b\u5206\u92b7\u5b83\u7684\u7d0d\u7d61\u916e\u5674\u9727\u5291\u3002 \u7d0d\u6d1b\u916e\u73fe\u5728\u662f\u5982\u4f55\u5206\u92b7\u7684\uff1f \u5373\u4f7f\u5728FDA\u6700\u65b0\u6279\u51c6\u4e4b\u524d\uff0c\u85e5\u5e97\u5c31\u53ef\u5728\u6c92\u6709\u8655\u65b9\u7684\u60c5\u6cc1\u4e0b\u92b7\u552e\u7d0d\u6d1b\u916e\uff0c\u56e0\u70ba\u6bcf\u500b\u5dde\u7684\u5b98\u54e1\u90fd\u5141\u8a31\u9019\u6a23\u505a\u3002 \u4f46\u4e26\u4e0d\u662f\u6bcf\u500b\u85e5\u5e97\u90fd\u6709\u3002\u8cb7\u5bb6\u5fc5\u9808\u652f\u4ed8\u85e5\u7269\u8cbb\u7528\uff08\u4fdd\u96aa\u5171\u540c\u652f\u4ed8\u6216\u5168\u984d\u96f6\u552e\u50f9\uff09\u3002\u8cbb\u7528\u5404\u4e0d\u76f8\u540c\uff0c\u4f46\u5169\u5291Narcan\u7684\u50f9\u683c\u901a\u5e38\u572850\u5143\u5de6\u53f3\u3002 \u9019\u7a2e\u85e5\u7269\u4e5f\u7531\u70ba\u85e5\u7269\u4f7f\u7528\u8005\u670d\u52d9\u7684\u793e\u5340\u7d44\u7e54\u5206\u767c\uff0c\u4f46\u4e0d\u662f\u6bcf\u500b\u9700\u8981\u5b83\u7684\u4eba\u90fd\u80fd\u8f15\u6613\u7372\u5f97\u5b83\u3002 Emergent\u5c1a\u672a\u516c\u4f48Narcan\u50f9\u683c\uff0c\u4e5f\u4e0d\u6e05\u695a\u5982\u679cNarcan\u53ef\u5728\u6ac3\u6aaf\u8cfc\u8cb7\uff0c\u4fdd\u96aa\u516c\u53f8\u662f\u5426\u6703\u7e7c\u7e8c\u5c07\u5176\u4f5c\u70ba\u8655\u65b9\u85e5\u627f\u4fdd\u3002 \u7d0d\u6d1b\u916e\u6ac3\u6aaf\u92b7\u552e\u662f\u5426\u6539\u5584\u7372\u53d6\u9014\u5f91\uff1f \u5b83\u70baNarcan\u5728\u6c92\u6709\u85e5\u5e97\u7684\u5834\u6240\uff08\u4f8b\u5982\u4fbf\u5229\u5e97\u3001\u8d85\u5e02\u548c\u7dda\u4e0a\u96f6\u552e\u5546\uff09\u4f9b\u61c9\u6383\u6e05\u9053\u8def\u3002 \u4f46\u6709\u591a\u5c11\u5e97\u6703\u63d0\u4f9b\u7d0d\u6d1b\u916e\u4ee5\u53ca\u50f9\u683c\u5982\u4f55\u9084\u6709\u5f85\u89c0\u5bdf\u3002 U.S. Centers for Medicaid and Medicare Services\u73fe\u5728\u70ba\u653f\u5e9c\u4fdd\u96aa\u5c08\u6848\u4e2d\u7684\u4eba\u63d0\u4f9b\u8655\u65b9\u7d0d\u6d1b\u916e\u3002\u8a72\u4e2d\u5fc3\u8868\u793a\uff0c\u975e\u8655\u65b9\u7d0d\u6d1b\u916e\u7684\u8986\u84cb\u7bc4\u570d\u5c07\u53d6\u6c7a\u65bc\u4fdd\u96aa\u5c08\u6848\u3002\u8a72\u4e2d\u5fc3\u6c92\u6709\u7d66\u51fa\u4efb\u4f55\u5b98\u65b9\u6307\u5c0e\u3002 Remedy Alliance\/For The People\u806f\u5408\u4e3b\u4efbMaya Doe Simkins\u8868\u793a\uff0c\u5979\u7684\u7d44\u7e54\u5c07\u7e7c\u7e8c\u5206\u767c\u53ef\u6ce8\u5c04\u7d0d\u6d1b\u916e\u3002\u8a72\u7d44\u7e54\u53bb\u5e74\u6210\u7acb\uff0c\u65e8\u5728\u5411\u793e\u5340\u7d44\u7e54\u63d0\u4f9b\u4f4e\u6210\u672c\u3001\u6709\u6642\u662f\u514d\u8cbb\u7684\u7d0d\u6d1b\u916e\u3002 \u6ac3\u6aaf\u92b7\u552e\u6709\u7f3a\u9ede\u55ce\uff1f Stanford\u5927\u5b78\u6210\u766e\u5c08\u5bb6Keith Humphreys\u8aaa\uff0c\u4e00\u500b\u4ee4\u4eba\u64d4\u6182\u7684\u554f\u984c\u662f\uff1a\u8cfc\u8cb7Narcan\u975e\u8655\u65b9\u85e5\u7684\u4eba\u662f\u5426\u77e5\u9053\u5982\u4f55\u6b63\u78ba\u4f7f\u7528\u5b83\uff0c\u5118\u7ba1\u88fd\u9020\u5546\u8ca0\u8cac\u63d0\u4f9b\u9019\u65b9\u9762\u7684\u660e\u78ba\u8aaa\u660e\u548c\u7dda\u4e0a\u8996\u983b\u3002 \u4ed6\u8aaa\uff0c\u8b93\u85e5\u5291\u5e2b\u53c3\u8207\u9032\u4f86\u7684\u4e00\u500b\u597d\u8655\u662f\u4ed6\u5011\u53ef\u4ee5\u5411\u8cb7\u5bb6\u5c55\u793a\u5982\u4f55\u4f7f\u7528\u7d0d\u6d1b\u916e\u3002\u9700\u8981\u63d0\u9192\u4eba\u5011\u7684\u4e00\u4ef6\u95dc\u9375\u4e8b\u60c5\u662f\uff1a\u5728\u65bd\u7528\u7d0d\u6d1b\u916e\u6642\uff0c\u70ba\u63a5\u53d7\u7d0d\u6d1b\u916e\u7684\u4eba\u53eb\u6551\u8b77\u8eca\u3002 \u4ed6\u9084\u8868\u793a\uff0c\u6709\u4eba\u64d4\u5fc3\uff0c\u5982\u679c\u9019\u7a2e\u85e5\u7269\u4f5c\u70ba\u975e\u8655\u65b9\u85e5\u7121\u6cd5\u76c8\u5229\uff0c\u5236\u85e5\u5546\u53ef\u80fd\u6703\u505c\u6b62\u751f\u7522\u3002\" \/>\n\t\t<meta property=\"og:url\" content=\"https:\/\/newsforchinese.com\/v3\/2023\/04\/02\/fda%e6%89%b9%e5%87%86%e7%b4%8d%e6%b4%9b%e9%85%ae%e6%ab%83%e6%aa%af%e9%8a%b7%e5%94%ae\/\" \/>\n\t\t<meta property=\"og:image\" content=\"https:\/\/newsforchinese.com\/v3\/wp-content\/uploads\/2023\/04\/FDA-approves-over-the-counter-Narcan.jpg\" \/>\n\t\t<meta property=\"og:image:secure_url\" content=\"https:\/\/newsforchinese.com\/v3\/wp-content\/uploads\/2023\/04\/FDA-approves-over-the-counter-Narcan.jpg\" \/>\n\t\t<meta property=\"og:image:width\" content=\"600\" \/>\n\t\t<meta property=\"og:image:height\" content=\"400\" \/>\n\t\t<meta property=\"article:published_time\" content=\"2023-04-02T15:33:49+00:00\" \/>\n\t\t<meta property=\"article:modified_time\" content=\"2023-04-02T15:33:51+00:00\" \/>\n\t\t<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n\t\t<meta name=\"twitter:title\" content=\"FDA\u6279\u51c6\u7d0d\u6d1b\u916e\u6ac3\u6aaf\u92b7\u552e - News for Chinese \uff0d \u820a\u91d1\u5c71\u7063\u5340No.1\u514d\u8cbb\u83ef\u4eba\u793e\u5340\u5831\u7d19\" \/>\n\t\t<meta name=\"twitter:description\" content=\"U.S. Food and Drug Administration\u9031\u4e09\u6279\u51c6\u5728\u6c92\u6709\u8655\u65b9\u60c5\u6cc1\u4e0b\u92b7\u552e\u7d0d\u6d1b\u916e\uff08naloxone\uff09\uff0c\u9019\u7a2e\u85e5\u7269\u56e0\u6b64\u5373\u5c07\u6210\u70ba\u7b2c\u4e00\u7a2e\u6ac3\u6aaf\u92b7\u552e\u7684\u963f\u7247\u6cbb\u7642\u85e5\u7269\u3002 \u4ee5\u4e0b\u662f\u4e00\u4e9b\u57fa\u672c\u554f\u984c\u3002 \u4ec0\u9ebc\u662fNarcan\uff1f \u5b83\u662fEmergent BioSolutions\u88fd\u9020\u7684\u7d93\u6279\u51c6\u54c1\u724c\u9f3b\u5674\u9727\u5291\uff0c\u662f\u6700\u8457\u540d\u7684\u7d0d\u6d1b\u916e\u5f62\u5f0f\u3002Emergent BioSolutions\u7e3d\u90e8\u5728Maryland\u7684Gaithersburg\u3002 \u5b83\u53ef\u4ee5\u9006\u8f49\u5305\u62ec\u6d77\u6d1b\u56e0\u548c\u82ac\u592a\u5c3c\u7b49\u8857\u982d\u85e5\u7269\u4ee5\u53ca\u7fa5\u8003\u916e\u7b49\u8655\u65b9\u85e5\u5728\u5167\u7684\u963f\u7247\u985e\u85e5\u7269\u904e\u91cf\u4f7f\u7528\u3002 \u5ee3\u6cdb\u63d0\u4f9b\u7d0d\u6d1b\u916e\u88ab\u8996\u70ba\u63a7\u5236\u5168\u570b\u85e5\u7269\u904e\u91cf\u5371\u6a5f\u7684\u95dc\u9375\u7b56\u7565\u3002\u8a72\u5371\u6a5f\u5df2\u5c0e\u81f4\u5168\u570b\u6bcf\u5e74\u8d85\u904e10\u842c\u4eba\u6b7b\u4ea1\uff0c\u9019\u4e9b\u6b7b\u4ea1\u591a\u6578\u8207\u963f\u7247\u985e\u85e5\u7269\u6709\u95dc\uff0c\u4e3b\u8981\u662f\u5f37\u6548\u5408\u6210\u85e5\u7269\uff0c\u5982\u82ac\u592a\u5c3c\u3002\u5f37\u6548\u5408\u6210\u85e5\u7269\u53ef\u4ee5\u901a\u904e\u591a\u5291\u91cf\u7d0d\u6d1b\u916e\u9006\u8f49\u3002 \u652f\u6301\u8005\u8a8d\u70ba\uff0c\u8b93\u6700\u6709\u53ef\u80fd\u85e5\u7269\u904e\u91cf\u7684\u4eba\uff08\u5305\u62ec\u85e5\u7269\u4f7f\u7528\u8005\u53ca\u5176\u89aa\u5c6c\uff09\u7372\u5f97\u7d0d\u6d1b\u916e\u5f88\u91cd\u8981\u3002 \u8b66\u54e1\u548c\u5176\u4ed6\u6025\u6551\u4eba\u54e1\u4e5f\u7d93\u5e38\u651c\u5e36\u5b83\u3002 FDA\u6279\u51c6\u610f\u5473\u8457\u4ec0\u9ebc\uff1f Emergent BioSolutions\u8868\u793a\uff0cNarcan\u5c07\u65bc\u590f\u672b\u5728\u975e\u8655\u65b9\u85e5\u5e02\u5834\u4e0a\u5e02\u3002 \u5176\u4ed6\u54c1\u724c\u7d0d\u6d1b\u916e\u548c\u6ce8\u5c04\u5f62\u5f0f\u5c46\u6642\u9084\u4e0d\u6703\u5728\u6ac3\u6aaf\u51fa\u552e\uff0c\u4f46\u96e2\u4e0a\u5e02\u6642\u9593\u4e0d\u6703\u592a\u4e45\u3002 \u5f97\u5230OxyContin\u88fd\u9020\u5546Purdue Pharma\u8cc7\u52a9\u7684\u975e\u71df\u5229Harm Reduction Therapeutics Inc.\u5df2\u5411FDA\u63d0\u4ea4\u4e00\u4efd\u7533\u8acb\uff0c\u8acb\u6c42\u5728\u6c92\u6709\u8655\u65b9\u60c5\u6cc1\u4e0b\u5206\u92b7\u5b83\u7684\u7d0d\u7d61\u916e\u5674\u9727\u5291\u3002 \u7d0d\u6d1b\u916e\u73fe\u5728\u662f\u5982\u4f55\u5206\u92b7\u7684\uff1f \u5373\u4f7f\u5728FDA\u6700\u65b0\u6279\u51c6\u4e4b\u524d\uff0c\u85e5\u5e97\u5c31\u53ef\u5728\u6c92\u6709\u8655\u65b9\u7684\u60c5\u6cc1\u4e0b\u92b7\u552e\u7d0d\u6d1b\u916e\uff0c\u56e0\u70ba\u6bcf\u500b\u5dde\u7684\u5b98\u54e1\u90fd\u5141\u8a31\u9019\u6a23\u505a\u3002 \u4f46\u4e26\u4e0d\u662f\u6bcf\u500b\u85e5\u5e97\u90fd\u6709\u3002\u8cb7\u5bb6\u5fc5\u9808\u652f\u4ed8\u85e5\u7269\u8cbb\u7528\uff08\u4fdd\u96aa\u5171\u540c\u652f\u4ed8\u6216\u5168\u984d\u96f6\u552e\u50f9\uff09\u3002\u8cbb\u7528\u5404\u4e0d\u76f8\u540c\uff0c\u4f46\u5169\u5291Narcan\u7684\u50f9\u683c\u901a\u5e38\u572850\u5143\u5de6\u53f3\u3002 \u9019\u7a2e\u85e5\u7269\u4e5f\u7531\u70ba\u85e5\u7269\u4f7f\u7528\u8005\u670d\u52d9\u7684\u793e\u5340\u7d44\u7e54\u5206\u767c\uff0c\u4f46\u4e0d\u662f\u6bcf\u500b\u9700\u8981\u5b83\u7684\u4eba\u90fd\u80fd\u8f15\u6613\u7372\u5f97\u5b83\u3002 Emergent\u5c1a\u672a\u516c\u4f48Narcan\u50f9\u683c\uff0c\u4e5f\u4e0d\u6e05\u695a\u5982\u679cNarcan\u53ef\u5728\u6ac3\u6aaf\u8cfc\u8cb7\uff0c\u4fdd\u96aa\u516c\u53f8\u662f\u5426\u6703\u7e7c\u7e8c\u5c07\u5176\u4f5c\u70ba\u8655\u65b9\u85e5\u627f\u4fdd\u3002 \u7d0d\u6d1b\u916e\u6ac3\u6aaf\u92b7\u552e\u662f\u5426\u6539\u5584\u7372\u53d6\u9014\u5f91\uff1f \u5b83\u70baNarcan\u5728\u6c92\u6709\u85e5\u5e97\u7684\u5834\u6240\uff08\u4f8b\u5982\u4fbf\u5229\u5e97\u3001\u8d85\u5e02\u548c\u7dda\u4e0a\u96f6\u552e\u5546\uff09\u4f9b\u61c9\u6383\u6e05\u9053\u8def\u3002 \u4f46\u6709\u591a\u5c11\u5e97\u6703\u63d0\u4f9b\u7d0d\u6d1b\u916e\u4ee5\u53ca\u50f9\u683c\u5982\u4f55\u9084\u6709\u5f85\u89c0\u5bdf\u3002 U.S. Centers for Medicaid and Medicare Services\u73fe\u5728\u70ba\u653f\u5e9c\u4fdd\u96aa\u5c08\u6848\u4e2d\u7684\u4eba\u63d0\u4f9b\u8655\u65b9\u7d0d\u6d1b\u916e\u3002\u8a72\u4e2d\u5fc3\u8868\u793a\uff0c\u975e\u8655\u65b9\u7d0d\u6d1b\u916e\u7684\u8986\u84cb\u7bc4\u570d\u5c07\u53d6\u6c7a\u65bc\u4fdd\u96aa\u5c08\u6848\u3002\u8a72\u4e2d\u5fc3\u6c92\u6709\u7d66\u51fa\u4efb\u4f55\u5b98\u65b9\u6307\u5c0e\u3002 Remedy Alliance\/For The People\u806f\u5408\u4e3b\u4efbMaya Doe 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