{"id":66202,"date":"2018-11-30T01:00:00","date_gmt":"2018-12-07T03:59:41","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/12\/07\/497f9d23dc\/"},"modified":"2018-12-07T11:59:43","modified_gmt":"2018-12-07T03:59:43","slug":"497f9d23dc","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/66202\/","title":{"rendered":"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731"},"content":{"rendered":"<div class=\"bpp-post-content\">\n<section class=\"_135editor\"   style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section style=\"margin: 10px auto;display: flex;justify-content: center;align-items: center;\">\n<section style=\"width: 330px;\"><img class=\"\"     src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/9-1544155182.gif\" alt=\"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731\" title=\"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731\"  \/><\/section>\n<\/section>\n<\/section>\n<section  class=\"_135editor\" style=\"border-width: 0px;border-style: none;border-color: initial;box-sizing: border-box;\">\n<section style=\"width: 95%;height: 10px;background: rgb(239, 239, 226);margin-right: auto;margin-left: auto;\" ><\/section>\n<section style=\"width: 100%;border-width: 2px;border-style: solid;border-color: rgb(211, 210, 180);box-sizing: border-box;\" >\n<section style=\"margin-right: auto;margin-left: auto;line-height: 28px;color: rgb(65, 64, 64);word-break: break-word;text-align: justify;padding: 10px;box-sizing: border-box;\" class=\"135brush\">\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 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-apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 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normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u4ed6\u5c71\u4e4b\u77f3\uff0c\u53ef\u4ee5\u653b\u7389\u3002\u6211\u56fd\u5728\u8fdb\u884c\u5236\u5ea6\u8bbe\u8ba1\u548c\u5b9e\u65bd\u7684\u540c\u65f6\uff0c\u53ef\u4ee5\u501f\u9274\u7f8e\u56fd\u7684\u76f8\u5173\u7ecf\u9a8c\u3002\u5f53\u7136\uff0c\u4e00\u5207\u5de5\u4f5c\u7684\u57fa\u7840\uff0c\u90fd\u662f\u6211\u4eec\u5bf9\u7f8e\u56fd\u836f\u54c1\u4e0a\u5e02\u5ba1\u6279\u5236\u5ea6\u548c\u5176\u76f8\u5173\u77e5\u8bc6\u4ea7\u6743\u5236\u5ea6\u914d\u5408\u8bbe\u8ba1\u673a\u5236\u7684\u6df1\u5165\u4e86\u89e3\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u7f8e\u56fd\u836f\u54c1\u62a5\u6279\u8fc7\u7a0b\u4e2d\uff0c\u5bf9\u4e8e505(b)(1) \u65b0\u836f\u7533\u8bf7, 505(b)(2) \u65b0\u836f\u7533\u8bf7\u548c505(j) \u4eff\u5236\u836f\u7533\u8bf7\u8fd9\u4e09\u79cd\u7f8e\u56fd\u836f\u54c1\u5ba1\u6279\u8def\u5f84\uff0c\u6d89\u53ca\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u5404\u4e0d\u76f8\u540c\uff0c\u53ef\u4ee5\u5f52\u7ed3\u4e3a\u6570\u636e\u4fdd\u62a4\u5236\u5ea6\u548c\u4e13\u5229\u4fdd\u62a4\u5236\u5ea6\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<section  class=\"\" style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"padding-top: 10px;padding-bottom: 10px;max-width: 100%;box-sizing: border-box;border-top: 2px solid rgb(153, 153, 153);border-bottom: 1px solid rgb(222, 222, 222);line-height: 28px;word-wrap: break-word !important;\">\n<p style=\"padding-right: 12px;max-width: 100%;min-height: 1em;font-size: 20px;font-weight: bold;color: rgb(55, 74, 174);height: 1.3em;display: inline-block;border-color: rgb(55, 74, 174);background-image: url('http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/6-1544155183.png');background-attachment: initial;background-size: initial;background-origin: initial;background-clip: initial;background-position: 100% 12px;background-repeat: no-repeat;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08\u4e00\uff09\u6570\u636e\u4fdd\u62a4\u5236\u5ea6<\/span><\/p>\n<\/section>\n<\/section>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u6240\u8c13\u6570\u636e\u4fdd\u62a4\u5236\u5ea6 (Data Exclusivity)\uff0c\u662f\u836f\u54c1\u4e0a\u5e02\u540e\u5e02\u573a\u72ec\u5360\u4fdd\u62a4\u7684\u4e00\u79cd\u884c\u653f\u624b\u6bb5\uff0c\u7528\u4e8e\u4fdd\u62a4\u65b0\u836f\u5f00\u53d1\u5546\u81ea\u4e3b\u8fdb\u884c\u836f\u54c1\u5f00\u53d1\u7684\u6295\u8d44\u5229\u76ca\u548c\u79ef\u6781\u6027\u3002\u5177\u4f53\u6307\u5728\u836f\u54c1\u4e0a\u5e02\u6279\u51c6\u8fc7\u7a0b\u4e2d\uff0c\u7533\u8bf7\u8005\u5fc5\u987b\u5411FDA\u63d0\u4ea4\u4e0e\u836f\u54c1\u7814\u53d1\u76f8\u5173\u7684\u672a\u62ab\u9732\u8bd5\u9a8c\u6570\u636e\uff0c\u4ee5\u8bc1\u660e\u5176\u7533\u8bf7\u6ce8\u518c\u836f\u54c1\u7684\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\uff0c\u5728\u4e00\u5b9a\u7684\u4fdd\u62a4\u671f\u5185\uff0cFDA 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100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u6839\u636e\u4e09\u79cd\u5ba1\u6279\u8def\u5f84\u9002\u7528\u5bf9\u8c61\u7684\u5dee\u5f02\u53ef\u77e5\uff0c\u6570\u636e\u4fdd\u62a4\u5236\u5ea6\u4e3b\u8981\u9002\u7528\u4e8e505(b)(1) \u65b0\u836f\u7533\u8bf7\u548c505(b)(2) \u65b0\u836f\u7533\u8bf7\u3002\u5177\u4f53\u7684\u6570\u636e\u4fdd\u62a4\u7c7b\u578b\u53ca\u4fdd\u62a4\u65b9\u5f0f\uff0c\u89c4\u5b9a\u4e8e\u7f8e\u56fd\u8054\u90a6\u6cd5\u89c4\u6c47\u7f1621CFR314.108\uff0c\u8bf7\u53c2\u89c1\u4e0b\u8868\uff1a<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;widows: 1;text-align: center;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       style=\"box-sizing: border-box !important;word-wrap: break-word !important;width: 677px !important;visibility: visible !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/8-1544155182.png\" alt=\"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731\" title=\"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<section  class=\"\" style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"padding-top: 10px;padding-bottom: 10px;max-width: 100%;box-sizing: border-box;border-top: 2px solid rgb(153, 153, 153);border-bottom: 1px solid rgb(222, 222, 222);line-height: 28px;word-wrap: break-word !important;\">\n<p style=\"padding-right: 12px;max-width: 100%;min-height: 1em;font-size: 20px;font-weight: bold;color: rgb(55, 74, 174);height: 1.3em;display: inline-block;border-color: rgb(55, 74, 174);background-image: url('http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/6-1544155183.png');background-attachment: initial;background-size: initial;background-origin: initial;background-clip: initial;background-position: 100% 12px;background-repeat: no-repeat;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08\u4e8c\uff09\u4e13\u5229\u4fdd\u62a4\u5236\u5ea6<\/span><\/p>\n<\/section>\n<\/section>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u836f\u54c1\u7533\u62a5\u8fc7\u7a0b\u4e2d\u7684\u4e13\u5229\u4fdd\u62a4\u5236\u5ea6\uff0c\u53ef\u5177\u4f53\u4e3a\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u3002\u6240\u8c13\u836f\u54c1\u4e13\u5229\u94fe\u63a5\uff08patent linkage\uff09\uff0c\u662f\u6307\u836f\u54c1\u4e0a\u5e02\u6279\u51c6\u4e0e\u521b\u65b0\u836f\u54c1\u4e13\u5229\u671f\u6ee1\u76f8\u201c\u94fe\u63a5\u201d\uff0c\u5373\u836f\u54c1\u6ce8\u518c\u7533\u8bf7\u5e94\u5f53\u8003\u8651\u5148\u524d\u5df2\u4e0a\u5e02\u836f\u54c1\u7684\u4e13\u5229\u72b6\u51b5\uff0c\u4ece\u800c\u907f\u514d\u53ef\u80fd\u7684\u4e13\u5229\u4fb5\u6743\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u7f8e\u56fd\u8054\u90a6\u6cd5\u89c4\u6c47\u7f16\u4e2d\u5173\u4e8e\u836f\u54c1\u7684\u7ae0\u828221CFR 314.53 \u89c4\u5b9a\uff0c505(b)(1)\u7533\u8bf7\u4eba\u548c505(b)(2)\u7533\u8bf7\u4eba\u5728\u9012\u4ea4\u65b0\u836f\u7533\u8bf7\u65f6\u9700\u540c\u65f6\u63d0\u4ea4\u76f8\u5173\u4e13\u5229\u4fe1\u606f\uff0c\u65b0\u836f\u7533\u8bf7\u6279\u51c6\u540e\uff0cFDA\u4f1a\u5c06\u4e13\u5229\u4fe1\u606f\u5728\u6a58\u76ae\u4e66\u4e0a\u4e88\u4ee5\u516c\u5e03\u300221 CFR 314.50(i)\u8981\u6c42\uff0c505(b)(2)\u7533\u8bf7\u4eba\u548c505(j)\u7533\u8bf7\u4eba\u5728\u9012\u4ea4\u7533\u8bf7\u65f6\u9700\u5bf9\u6a58\u76ae\u4e66\u4e2d\u6240\u5217\u53c2\u6bd4\u836f\u7269\u7684\u76f8\u5173\u4e13\u5229\u9010\u4e2a\u63d0\u4ea4\u58f0\u660e\uff0c\u5e76\u5c06\u76f8\u5173\u4e0d\u4fb5\u6743\u58f0\u660e\u9012\u4ea4NDA \u6240\u6709\u6743\u4eba\/\u4e13\u5229\u6743\u4eba\u3002\u5176\u4e2d\uff0c\u4e13\u5229\u58f0\u660e\u5305\u62ec\u56db\u79cd\uff1a<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(136, 136, 136);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u2460\u6a58\u76ae\u4e66\u4e2d\u6ca1\u6709\u76f8\u5173\u4e13\u5229\uff0c\u7533\u8bf7\u4eba\u5e94\u9012\u4ea4\u201c\u7b2cI \u9636\u6bb5\u58f0\u660e\u201d\uff1b<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(136, 136, 136);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u2461\u76f8\u5173\u4e13\u5229\u5df2\u7ecf\u8fc7\u671f\uff0c\u7533\u8bf7\u4eba\u5e94\u9012\u4ea4 \u201c\u7b2cII \u9636\u6bb5\u58f0\u660e\u201d\uff1b<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(136, 136, 136);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u2462\u867d\u6709\u4e13\u5229\uff0c\u4f46\u7533\u8bf7\u4ea7\u54c1\u5c06\u4e8e\u4e13\u5229\u671f\u5c4a\u6ee1\u540e\u4e0a\u5e02\uff0c\u7533\u8bf7\u4eba\u5e94\u9012\u4ea4\u201c\u7b2cIII \u9636\u6bb5\u58f0\u660e\u201d\uff1b<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(136, 136, 136);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">\u2463\u8ba4\u4e3a\u4e13\u5229\u4e0d\u53ef\u6267\u884c\u3001\u4e13\u5229\u65e0\u6548\uff0c\u6216\u5236\u9020\u3001\u4f7f\u7528\u53ca\u9500\u552e\u7533\u8bf7\u836f\u54c1\u65f6\u4e0d\u4fb5\u72af\u4e13\u5229\u6743\uff0c\u7533\u8bf7\u4eba\u5e94\u9012\u4ea4\u201c\u7b2cIV \u9636\u6bb5\u58f0\u660e\u201d\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u6b64\u5916\uff0c\u5bf9\u4e8e\u7528\u9014\u4e13\u5229\uff0c\u82e5\u7533\u62a5\u7684\u836f\u54c1\u7528\u9014\u672a\u6db5\u76d6\u5728\u53c2\u6bd4\u836f\u7269\u6a58\u76ae\u4e66\u6240\u5217\u7528\u9014\u4e13\u5229\u4e2d\uff0c\u5219\u4eff\u5236\u836f\u5546\u53ea\u9700\u63d0\u4ea4\u4e00\u4e2a\u7b2c\u2167\u8282\u58f0\u660e\u5373\u53ef<span style=\"max-width: 100%;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">[1]<\/strong><\/span>\u3002\u8be5\u58f0\u660e\u7684\u4f7f\u7528\u524d\u63d0\u4e3aFDA \u6279\u51c6\u7684\u836f\u54c1\u7528\u9014\u5e76\u6ca1\u6709\u88ab\u539f\u7814\u836f\u5546\u7528\u9014\u4e13\u5229\u6240\u7a77\u5c3d\uff0c\u7533\u8bf7\u4eba\u53ef\u9009\u62e9\u4e0d\u4fb5\u72af\u4e13\u5229\u6743\u7684\u591a\u4e2a\u6216\u4e00\u4e2a\u7528\u9014\u6765\u7533\u8bf7\u4e0a\u5e02\uff0c\u5373\u6240\u8c13\u7684\u836f\u54c1\u6807\u7b7e\u4f8b\u5916\uff08crave-out\uff09<span style=\"max-width: 100%;color: rgb(2, 30, 170);box-sizing: border-box !important;word-wrap: break-word !important;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">[2]<\/strong><\/span>\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<section  class=\"\" style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"padding-top: 10px;padding-bottom: 10px;max-width: 100%;box-sizing: border-box;border-top: 2px solid rgb(153, 153, 153);border-bottom: 1px solid rgb(222, 222, 222);line-height: 28px;word-wrap: break-word !important;\">\n<p style=\"padding-right: 12px;max-width: 100%;min-height: 1em;font-size: 20px;font-weight: bold;color: rgb(55, 74, 174);height: 1.3em;display: inline-block;border-color: rgb(55, 74, 174);background-image: url('http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/6-1544155183.png');background-attachment: initial;background-size: initial;background-origin: initial;background-clip: initial;background-position: 100% 12px;background-repeat: no-repeat;line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(2, 30, 170);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">\uff08\u4e09\uff09\u4e13\u5229\u94fe\u63a5\u5236\u5ea6\u7684\u7ea0\u7eb7\u89e3\u51b3\u673a\u5236<\/span><\/p>\n<\/section>\n<\/section>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u53c2\u6bd4\u836f\u7269\u6279\u4ef6\u6301\u6709\u4eba\u5728\u6536\u5230\u7b2c\u2163\u6bb5\u58f0\u660e\u4e4b\u65e5\u8d7745 \u65e5\u5185\uff0c\u53ef\u4ee5\u5411\u8054\u90a6\u6cd5\u9662\u63d0\u8d77\u8bc9\u8bbc\uff0c\u8981\u6c42\u88c1\u5b9a\u76f8\u5173\u4e13\u5229\u6709\u6548\uff0c\u548c\/\u6216505(b)(2)\u7533\u8bf7\u4eba\u548c505(j)\u7533\u8bf7\u4eba\u4fb5\u6743\uff0c\u5e76\u901a\u77e5FDA \u8054\u90a6\u6cd5\u9662\u5df2\u7ecf\u53d7\u7406\u6709\u5173\u8bc9\u8bbc\u3002\u4f46\u5982\u679c\u63a5\u5230\u901a\u77e545 \u5929\u4e4b\u5185\uff0c\u53c2\u6bd4\u836f\u7269\u6279\u4ef6\u6301\u6709\u4eba\u5e76\u672a\u5411\u6cd5\u9662\u63d0\u8d77\u8bc9\u8bbc\u8bf7\u6c42\uff0c\u5219\u7ecf\u8fc7\u7b26\u5408\u6761\u4ef6\u7684\u6750\u6599\u8bc4\u5ba1\uff0cFDA \u4fbf\u53ef\u6279\u51c6\u4ea7\u54c1\u4e0a\u5e02\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u5982\u679c\u53c2\u6bd4\u836f\u7269\u6279\u4ef6\u6301\u6709\u4eba\u63d0\u8d77\u8bc9\u8bbc\uff0c\u4f9d\u716721 U.S.C. \u00a7 355(c)\u89c4\u5b9a\uff0cFDA \u5c06\u7ed9\u4e88\u53c2\u6bd4\u836f\u7269\u6279\u4ef6\u6301\u6709\u4eba30 \u4e2a\u6708\u7684\u65f6\u95f4\u89e3\u51b3\u4e13\u5229\u7ea0\u7eb7\uff0c\u540c\u65f6FDA\u4f1a\u5bf9\u4ea7\u54c1\u7ee7\u7eed\u5ba1\u8bc4\uff0c\u4f46\u6279\u51c6\u4f1a\u81ea\u52a8\u63a8\u5ef630 \u4e2a\u6708\u3002\u82e5\u5728\u6b64\u671f\u95f4FDA\u5b8c\u6210\u5ba1\u8bc4\uff0c\u5e76\u786e\u8ba4\u8be5\u836f\u54c1\u7b26\u5408\u201c\u5b89\u5168\u6027\u3001\u6709\u6548\u6027\u3001\u8d28\u91cf\u53ef\u63a7\u6027\u201d\u8981\u6c42\uff0c\u4f1a\u9881\u53d1\u4e34\u65f6\u6279\u51c6\uff08Tentative Approval\uff09\u3002\u9700\u8981\u6ce8\u610f\u7684\u662f\uff0c\u7533\u8bf7\u4eba\u4e0d\u80fd\u57fa\u4e8e\u4e34\u65f6\u6279\u51c6\u5c06\u836f\u54c1\u4e0a\u5e02\uff0c\u76f4\u81f3\u6cd5\u9662\u5224\u5b9a\u4fb5\u6743\u4e0d\u6210\u7acb\uff0c\u621630\u4e2a\u6708\u5ef6\u8fdf\u671f\u7ed3\u675f\uff0cFDA\u9881\u5e03\u6700\u7ec8\u6279\u51c6\uff0c\u6240\u7533\u8bf7\u7684\u836f\u54c1\u624d\u80fd\u591f\u4e0a\u5e02\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u82e5\u572830\u4e2a\u6708\u5ef6\u8fdf\u671f\u5185\uff0c\u6cd5\u9662\u5224\u5b9a\u4e13\u5229\u4fb5\u6743\u6210\u7acb\u5219FDA\u7acb\u5373\u7ed3\u675f\u5ba1\u8bc4\uff0c\u836f\u54c1\u4e0d\u4e88\u6279\u51c6\u4e0a\u5e02\u3002\u53cd\u4e4b\uff0cFDA \u7ee7\u7eed\u5ba1\u8bc4\uff0c\u6216\u5ba1\u8bc4\u901a\u8fc7\u540e\u9881\u53d1\u6700\u7ec8\u4ea7\u54c1\u4e0a\u5e02\u6279\u51c6\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\">\u5982\u679c\u572830 \u4e2a\u6708\uff08\u6216\u5bbd\u9650\u671f\uff09\u5185\uff0c\u4e13\u5229\u7ea0\u7eb7\u6ca1\u6709\u7ed3\u675f\uff0cFDA \u4e5f\u5c06\u6279\u51c6\u8be5\u836f\u54c1\u4e0a\u5e02\u3002\u4f46\u6700\u540e\u5982\u82e5\u5224\u5b9a\u4fb5\u6743\u6210\u7acb\uff0c\u836f\u54c1\u5382\u5546\u5c06\u9762\u4e34\u5de8\u989d\u7684\u60e9\u7f5a\u6027\u4fb5\u6743\u8d54\u507f\u3002<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"><br style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\"  \/><\/p>\n<hr style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;line-height: 27.2px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);box-sizing: border-box !important;word-wrap: break-word !important;\"  \/>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"font-size: 16px;letter-spacing: 0.5px;\"><strong style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u6ce8\u91ca\uff1a<\/strong><\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(136, 136, 136);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">[1]See generic labeling regulations implemented in 1992.<\/span><\/p>\n<p style=\"font-variant-numeric: normal;font-variant-east-asian: normal;white-space: normal;max-width: 100%;min-height: 1em;color: rgb(51, 51, 51);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 17px;letter-spacing: 0.544px;text-align: justify;widows: 1;background-color: rgb(255, 255, 255);line-height: 1.5em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(136, 136, 136);font-size: 16px;letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;\">[2] Applications for FDA Approval to Market a New Drug, 68 Fed. Reg. 36676, 36682 (June 18, 2003).<\/span><\/p>\n<\/section>\n<section style=\"width: 100%;\" ><img class=\"\"      style=\"width: 100%;display: block;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/4-1544155183.png\" alt=\"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731\" title=\"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731\"  \/><\/section>\n<\/section>\n<section style=\"width: 95%;height: 10px;background: rgb(239, 239, 226);margin-right: auto;margin-left: auto;\" ><\/section>\n<\/section>\n<section class=\"\"  style=\"white-space: normal;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"padding-right: 10px;padding-left: 10px;max-width: 100%;box-sizing: border-box;text-align: justify;font-size: 15px;line-height: 1.8;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;box-sizing: border-box;min-height: 1em;text-align: left;word-wrap: break-word !important;\"><strong style=\"font-size: 14px;\">\u3010\u8f6c\u81ea\uff1a<\/strong><span style=\"color: rgb(0, 0, 0);\"><strong style=\"font-size: 14px;\"><strong style=\"max-width: 100%;color: rgb(62, 62, 62);font-family: -apple-system-font, BlinkMacSystemFont, &quot;Helvetica Neue&quot;, &quot;PingFang SC&quot;, &quot;Hiragino Sans GB&quot;, &quot;Microsoft YaHei UI&quot;, &quot;Microsoft YaHei&quot;, Arial, sans-serif;font-size: 16px;font-variant-numeric: normal;font-variant-east-asian: normal;letter-spacing: 0.544px;line-height: 25.6px;text-align: justify;white-space: normal;widows: 1;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;font-size: 14px;box-sizing: border-box !important;word-wrap: break-word !important;\">IPRdaily\u4e2d\u6587\u7f51<\/span><\/strong><\/strong><\/span><strong style=\"font-size: 14px;\">\u3011<\/strong><br  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"  style=\"white-space: normal;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 20px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;box-sizing: border-box;display: inline-block;width: 677px;vertical-align: top;word-wrap: break-word !important;\">\n<section class=\"\"  style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section class=\"\" style=\"margin-top: 0.5em;margin-bottom: 0.5em;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section px=\"px\" border-box=\"border-box\" 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62);\">\n<section style=\"padding: 10px;max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section class=\"\" style=\"max-width: 100%;line-height: 28px;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><img class=\"\"       width=\"auto\" style=\"letter-spacing: 0.5px;box-sizing: border-box !important;word-wrap: break-word !important;visibility: visible !important;width: auto !important;\" src=\"http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/9-1544155183.jpeg\" alt=\"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731\" title=\"\u7f8e\u56fd\u4e0d\u540c\u836f\u54c1\u7533\u62a5\u8def\u5f84\u7684\u77e5\u8bc6\u4ea7\u6743\u95ee\u9898\u2014\u2014\u57f9\u4f18\u7cbe\u9009|\u77e5\u8bc6\u4ea7\u6743\u7cfb\u521731\"  \/><\/p>\n<\/section>\n<\/section>\n<\/section>\n<section class=\"\"   style=\"max-width: 100%;color: rgb(62, 62, 62);\">\n<section  style=\"max-width: 100%;width: 558px;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"margin: 10px auto;max-width: 100%;width: 280px;height: 110px;background-image: url('http:\/\/www.05921.net\/wp-content\/uploads\/2018\/12\/10-1544155183.jpeg');background-repeat: no-repeat;background-size: 100%;overflow: hidden;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"margin-top: 8px;margin-left: 180px;max-width: 100%;width: 95px;box-sizing: border-box !important;word-wrap: break-word !important;\"><\/section>\n<\/section>\n<\/section>\n<\/section>\n<section label=\"Powered by 135editor.com\"  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hidden;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section  style=\"max-width: 100%;line-height: 25.6px;box-sizing: border-box !important;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"margin-top: 10px;margin-bottom: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"display: inline-block;max-width: 100%;box-sizing: border-box;border-radius: 0.7em;border-width: 0.14em;border-style: solid;border-color: rgb(0, 0, 0);width: 556px;box-shadow: rgb(204, 204, 204) 0.2em 0.2em 0.3em;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"padding: 10px;max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<section style=\"max-width: 100%;box-sizing: border-box;word-wrap: break-word !important;\">\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;color: rgb(171, 25, 66);box-sizing: border-box !important;word-wrap: break-word !important;\">\u514d\u8d23\u58f0\u660e\uff1a<\/span><\/p>\n<p style=\"max-width: 100%;min-height: 1em;box-sizing: border-box !important;word-wrap: break-word !important;\"><span style=\"max-width: 100%;box-sizing: border-box !important;word-wrap: break-word !important;\">\u672c\u6587\u4fe1\u606f\u90e8\u5206\u5185\u5bb9\u6765\u81ea\u7f51\u7edc\u6587\u7ae0\uff0c\u4e0d\u4fdd\u8bc1\u6240\u6709\u4fe1\u606f\u3001\u6587\u672c\u3001\u56fe\u5f62\u3001\u94fe\u63a5\u53ca\u5176\u4ed6\u9879\u76ee\u7684\u7edd\u5bf9\u51c6\u786e\u6027\u548c\u5b8c\u6574\u6027\uff0c\u6545\u4ec5\u4f9b\u8bbf\u95ee\u8005\u53c2\u7167\u9002\u7528\u3002\u5982\u60a8\uff08\u5355\u4f4d\u6216\u4e2a\u4eba\uff09\u8ba4\u4e3a\u672c\u6587\u67d0\u90e8\u5206\u5185\u5bb9\u6709\u4fb5\u6743\u5acc\u7591\uff0c\u656c\u8bf7\u7acb\u5373\u901a\u77e5\u6211\u4eec\uff0c\u6211\u4eec\u5c06\u5728\u7b2c\u4e00\u65f6\u95f4\u4e88\u4ee5\u66f4\u6b63\u6216\u5220\u9664\u3002\u4ee5\u4e0a\u58f0\u660e\u4e4b\u89e3\u91ca\u6743\u5f52\u672c\u516c\u4f17\u53f7\u6240\u6709\u3002\u6cd5\u5f8b\u4e0a\u6709\u76f8\u5173\u89e3\u91ca\u7684\uff0c\u4ee5\u4e2d\u56fd\u6cd5\u5f8b\u4e4b\u89e3\u91ca\u4e3a\u57fa\u51c6\u3002\u5982\u6709\u4e89\u8bae\u9650\u5728\u6211\u65b9\u6240\u5728\u5730\u53f8\u6cd5\u90e8\u95e8\u89e3\u51b3\u3002\u8c22\u8c22\u3002<\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section>\n<\/section><\/div>\n","protected":false},"excerpt":{"rendered":"<p>\u836f\u54c1\u4f5c\u4e3a\u4e00\u79cd\u7279\u6b8a\u5546\u54c1\uff0c\u5fc5\u987b\u786e\u4fdd\u5176\u53ef\u53ca\u6027\uff0c\u624d\u80fd\u4fdd\u969c\u793e\u4f1a\u516c\u4f17\u7684\u5065\u5eb7\u798f\u5229\u3002\u836f\u54c1\u53ef\u53ca\u6027\uff0c\u4e00\u65b9\u9762\u6d89\u53ca\u901a\u8fc7\u9f13\u52b1\u521b\u65b0\u589e\u52a0\u57fa\u672c [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":66203,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[2],"tags":[],"_links":{"self":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66202"}],"collection":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/comments?post=66202"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66202\/revisions"}],"predecessor-version":[{"id":66210,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/66202\/revisions\/66210"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/66203"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=66202"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=66202"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=66202"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}