{"id":19937,"date":"2018-07-21T01:00:00","date_gmt":"2018-08-08T01:15:37","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/08\/fda%e5%85%b3%e4%ba%8e%e5%88%bb%e7%97%95%e7%89%87%e7%a0%94%e7%a9%b6%e7%9a%84%e8%a6%81%e6%b1%82%e5%92%8c%e5%bb%ba%e8%ae%ae\/"},"modified":"2018-08-08T09:15:39","modified_gmt":"2018-08-08T01:15:39","slug":"fda%e5%85%b3%e4%ba%8e%e5%88%bb%e7%97%95%e7%89%87%e7%a0%94%e7%a9%b6%e7%9a%84%e8%a6%81%e6%b1%82%e5%92%8c%e5%bb%ba%e8%ae%ae","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/19937\/","title":{"rendered":"FDA\u5173\u4e8e\u523b\u75d5\u7247\u7814\u7a76\u7684\u8981\u6c42\u548c\u5efa\u8bae"},"content":{"rendered":"
\n

\u8ba8\u8bba\uff1a\u5c0f\u7f16\u6700\u8fd1\u6240\u5728\u516c\u53f8\u6709\u4e00\u4ea7\u54c1\u8fdb\u884c<\/span>FDA<\/span>\u6ce8\u518c\u7533\u62a5\uff0c\u5206\u522b\u6709<\/span>2.5mg<\/span>\u3001<\/span>5mg<\/span>\u3001<\/span>10mg<\/span>\uff0c\u4f46<\/span>5mg<\/span>\u4e3a\u523b\u75d5\u7247\uff0c\u6309\u7167<\/span>FDA<\/span>\u73b0\u6709\u6307\u5bfc\u539f\u5219\u9700\u8fdb\u884c\u534a\u7247\u7814\u7a76\u3002\u8be5<\/span>5mg<\/span>\u89c4\u683c\u7684\u7247\uff0c\u76f4\u5f84\u5927\u6982<\/span>5mm<\/span>\uff0c\u8fd9\u4e2a\u4ea7\u54c1\u65e2\u6709\u534a\u7247\u5242\u91cf\u89c4\u683c\u53c8\u4e0d\u5b58\u5728\u541e\u670d\u56f0\u96be\uff0c\u81ea\u5df1\u6709\u4e9b\u7591\u60d1\u4e3a\u4f55\u505a\u6210\u523b\u75d5\u7247\u3002\u540c\u65f6<\/span>\u6700\u8fd1\u4e00\u670b\u53cb\u516c\u53f8\u6536\u5230<\/span>CFDA<\/span>\u5173\u4e8e\u67d0\u4e00\u4ea7\u54c1\u7684\u53d1\u8865\uff0c\u539f\u8bdd\u63cf\u8ff0\u201c\u8bf7\u6309\u7167<\/span>FDA<\/span>\u76f8\u5173\u6307\u5bfc\u539f\u5219\u8fdb\u884c\u523b\u75d5\u7247\u7814\u7a76\u201d\uff0c\u867d\u7136\u56fd\u5185\u6ca1\u6709\u76f8\u5173\u6307\u5bfc\u6587\u4ef6\uff0c\u4f46<\/span>CFDA<\/span>\u4e5f\u5f88\u5173\u5fc3\u523b\u75d5\u7247\u662f\u5426\u80fd\u591f\u5230\u8fbe\u51c6\u786e\u62c6\u5206\u5242\u91cf\u7684\u6548\u679c\u3002\u4eca\u5929\u5c0f\u7f16\u60f3\u8ddf\u5927\u5bb6\u5206\u4eab\u4e00\u4e0b\u5982\u4f55\u8fdb\u884c\u534a\u7247\u7814\u7a76\u3002<\/span><\/span><\/p>\n


<\/span><\/span><\/p>\n

FDA<\/span>\u5728<\/span>2013<\/span>\u5e74\u53d1\u5e03\u4e86\u5173\u4e8e\u7247\u523b\u75d5\u7684\u7814\u7a76\u7684\u6307\u5bfc\u539f\u5219\uff0c\u8be5\u6307\u5bfc\u539f\u5219\u4e3b\u8981\u5bf9\u523b\u75d5\u7247\u7684\u7814\u7a76\u3001\u547d\u540d\u548c\u6807\u793a\u8bf4\u660e\u3002<\/span>\u523b\u75d5\u7247\u662f\u4e00\u79cd\u6bd4\u8f83\u7279\u522b\u7684\u7247\u5242\uff0c\u5b83\u65e2\u53ef\u4ee5\u6574\u7247\u670d\u7528\uff0c\u4e5f\u53ef\u4ee5\u63b0\u7247<\/span>(<\/span>\u4e00\u7247\u6216\u591a\u7247<\/span>)<\/span>\u540e\u670d\u7528\u3002\u523b\u75d5\u7684\u4e3b\u8981\u4f5c\u7528\u662f\u5728\u4e8e\u62c6\u5206\u5242\u91cf\u548c\u4fbf\u4e8e\u541e\u670d\u3002<\/span><\/p>\n


<\/span><\/p>\n

FDA<\/span>\u6307\u5bfc\u539f\u5219\u4e2d\u6307\u51fa\uff0c\u82e5\u53c2\u6bd4\u5236\u5242\u4e3a\u523b\u75d5\u7247\uff0c\u4eff\u5236\u836f\u5efa\u8bae\u4e0e\u53c2\u6bd4\u5236\u5242\u4fdd\u6301\u4e00\u81f4\u7684\u523b\u75d5\u3002<\/span>FDA<\/span>\u7684\u53e6\u4e00\u6307\u5bfc\u539f\u5219\u201c<\/span>ANDASubmissions-Refuse-to-Receive Standards<\/span>\u201d\u4e2d\u540c\u65f6\u4e5f\u63d0\u53ca\u5230\uff0c\u9664\u975e\u6709\u5f88\u660e\u786e\u7684\u3001\u5408\u7406\u7684\u7406\u7531\uff0c\u5426\u5219<\/span>FDA<\/span>\u4f1a\u62d2\u7edd\u4e0e<\/span>RLD<\/span>\u523b\u75d5\u4e0d\u4e00\u81f4\u7684\u4eff\u5236\u836f\u7533\u8bf7\u3002<\/span>CFDA<\/span>\u7684\u5f88\u591a\u89c2\u70b9\u548c\u60f3\u6cd5\u4e5f\u5728\u8ddf\u8fdb<\/span>FDA<\/span>\u3002\u56e0\u6b64\uff0c\u4e0d\u7ba1\u662f\u5728\u4e2d\u56fd\u8fd8\u662f\u7f8e\u56fd\u8fdb\u884c\u4ea7\u54c1\u6ce8\u518c\u7533\u62a5\uff0c\u5efa\u8bae\u7247\u5242\u662f\u5426\u6709\u523b\u75d5\u4e0e\u53c2\u6bd4\u5236\u5242\u4fdd\u6301\u4e00\u81f4\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u523b\u75d5\u7247\u5242\u7684\u6700\u5927\u98ce\u9669\u5728\u4e8e\u63b0\u7247\u5242\u91cf\u4e0d\u5747\u5300\uff0c\u5bf9\u4e8e\u67d0\u4e9b\u6cbb\u7597\u7a97\u72ed\u7a84\u7684\u836f\u7269<\/span>(<\/span>\u5982\u534e\u6cd5\u6797\u94a0\u3001\u5361\u9a6c\u897f\u5e73\u3001\u6251\u7c73\u916e\u7b49<\/span>)<\/span>\u6765\u8bf4\u53ef\u80fd\u4f1a\u4ea7\u751f\u8f83\u5927\u7684\u6cbb\u7597\u6548\u679c\uff1b\u800c\u5bf9\u4e8e\u5177\u6709\u8f83\u957f\u534a\u8870\u671f\u6216\u5bbd\u6cbb\u7597\u7a97\u7684\u836f\u7269\uff0c\u63b0\u7247\u5242\u91cf\u7684\u6ce2\u52a8\u4e0d\u4f1a\u4ea7\u751f\u8f83\u5927\u7684\u4e34\u5e8a\u540e\u679c\u3002\u65e2\u7136\u6709\u4e9b\u836f\u7269\u63b0\u7247\u540e\u5728\u4e34\u5e8a\u5e94\u7528\u4e2d\uff0c\u5b58\u5728\u4e00\u5b9a\u98ce\u9669\uff0c<\/span>FDA<\/span>\u53d1\u5e03\u7684\u8fd9\u4e2a\u6307\u5bfc\u539f\u5219\u5728\u4e00\u5b9a\u7a0b\u5ea6\u4e0a\u964d\u4f4e\u4e86\u8fd9\u79cd\u98ce\u9669\u3002<\/span><\/p>\n


<\/p>\n

\u523b\u75d5\u7247\u8d28\u91cf\u6807\u51c6\u63a7\u5236<\/span><\/p>\n

\u7247\u5242\u82e5\u63b0\u7247\u670d\u7528\uff0c\u5219\u5176\u5e94\u4e0e\u6574\u7247\u4e00\u6837\u4e5f\u4f5c\u4e3a\u4e00\u4e2a\u6cbb\u7597\u5242\u91cf\u7684\u6574\u4f53\u3002\u523b\u75d5\u7247\u5c06\u901a\u8fc7\u4ee5\u4e0b\u8fdb\u884c\u8bc4\u4f30\uff1a<\/span><\/p>\n

    \n
  1. \n

    \u63b0\u7247\u540e\u7684\u5355\u4f4d\u5242\u91cf\u4e0d\u80fd\u4f4e\u4e8e\u6700\u4f4e\u6cbb\u7597\u91cf\uff1b<\/span><\/p>\n<\/li>\n

  2. \n

    \u624b\u52a8\u63b0\u7247\u8fc7\u7a0b\u662f\u5b89\u5168\u7684\uff0c\u4e0d\u80fd\u9020\u6210\u610f\u5916\u7684\u836f\u7269\u66b4\u9732\u98ce\u9669\uff1b<\/span><\/p>\n<\/li>\n

  3. \n

    \u63b0\u7247\u540e\u4e0e\u6574\u7247\u836f\u7269\u7684\u91ca\u653e\u901f\u7387\u5e94\u4fdd\u6301\u4e00\u81f4\uff1b<\/span><\/p>\n<\/li>\n

  4. \n

    \u63b0\u7247\u540e\u7684\u836f\u7269\u5e94\u5728<\/span>25\u00b0C\u00b12\u00b0C \/ 60%RH\u00b15%RH<\/span>\u6761\u4ef6\u4e0b\uff0c90\u5929\u5185\u5177\u6709\u826f\u597d\u7684\u7a33\u5b9a\u6027\u3002<\/span><\/p>\n<\/li>\n

  5. \n

    \u5e94\u8bc4\u4f30\u63b0\u7247\u540e\u7684\u836f\u7269\u4e5f\u6ee1\u8db3\u6574\u7247\u7684\u8d28\u91cf\u6807\u51c6\uff0c\u8fd9\u4e2a\u8bc4\u4f30\u5e94\u5305\u542b\u624b\u52a8\u63b0\u7247\u548c\u5200\u5207\u4e24\u79cd\u65b9\u6cd5\u3002\u6eb6\u51fa\u8bd5\u9a8c\u5e94\u81f3\u5c11\u4f7f\u752812\u4e2a\u63b0\u7247\u540e\u7684\u6837\u54c1\u8fdb\u884c\u6d4b\u8bd5<\/span>\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


    <\/span><\/p>\n

    \u56fa\u4f53\u53e3\u670d\u901f\u91ca\u5236\u5242<\/span><\/p>\n

    \u5242\u91cf\u5747\u4e00\u6027<\/span><\/strong>\uff1a<\/span><\/span>\u4e0e\u6574\u7247\u4e00\u6837\u9700\u91cd\u91cf\u5747\u4e00\u6027\u6216\u542b\u91cf\u5747\u4e00\u6027\u7684\u8981\u6c42\u3002\u6839\u636e\u63b0\u7247\u540e\u7684\u5242\u91cf\u542b\u6709\u6d3b\u6027\u6210\u5206<\/span>\u226525mg<\/span>\u6216\u6d3b\u6027\u6210\u5206\u5728\u5904\u65b9\u4e2d\u5360\u6bd4<\/span>\u226525%<\/span>\uff0c\u53ef\u901a\u8fc7\u63b0\u7247\u540e\u7684\u534a\u7247\u7684\u91cd\u91cf\u5dee\u5f02\u63a7\u5236\u5242\u91cf\u5747\u4e00\u6027\uff1b\u82e5\u4e0d\u540c\u65f6\u6ee1\u8db3\u4e0a\u8ff0\u6761\u4ef6\uff0c\u5219\u63b0\u7247\u540e\u7684\u534a\u7247\u9700\u8fdb\u884c\u542b\u91cf\u5747\u4e00\u6027\u68c0\u6d4b\u63a7\u5236\u5242\u91cf\u5747\u4e00\u6027\u3002\u4e0d\u8bba\u662f\u91cd\u91cf\u5747\u4e00\u6027\u8fd8\u662f\u542b\u91cf\u5747\u4e00\u6027\uff0c\u5747\u6309\u7167<\/span>USP<905><\/span>\u8fdb\u884c\u6d4b\u8bd5\uff0c\u5e76\u6ee1\u8db3\u5176\u76f8\u5e94\u7684\u6807\u51c6\u3002<\/span><\/p>\n


    <\/span><\/p>\n

    \u63b0\u7247\u5e94\u6ee1\u8db3\u786c\u5ea6\u8981\u6c42\uff1a<\/span><\/strong><\/span>\u53d6<\/span>15<\/span>\u7247\u6574\u7247\uff0c\u63b0\u7247\u540e\u7684\u6240\u6709\u534a\u7247\uff08\u4e00\u6761\u523b\u75d5\u7684\u7247\u5242\uff0c\u5171<\/span>30<\/span>\u4e2a\u534a\u7247\uff0c\u4e00\u6761\u523b\u75d5\u7684\u7247\u5242\uff09\u4e0e<\/span>15<\/span>\u7247\u6574\u7247\u76f8\u6bd4\uff0c\u91cd\u91cf\u635f\u5931\u5e94\u63a7\u5236\u5728<\/span>3.0%<\/span>\u4ee5\u5185\uff1b\u8106\u788e\u5ea6\u5e94\u6309\u7167<\/span>USP<1216><\/span>\u8fdb\u884c\u68c0\u6d4b\uff0c\u5e76\u76f8\u5e94\u7684\u63a5\u53d7\u6807\u51c6\uff0c\u7247\u5242\u91cd\u91cf\u635f\u5931\u5728<\/span>1.0%<\/span>\u4ee5\u5185\u3002<\/span><\/p>\n


    <\/span><\/p>\n

    \u6eb6\u51fa\u5ea6\uff1a<\/span><\/strong><\/span>\u63b0\u7247\u540e\u7684\u534a\u7247\u5e94\u6ee1\u8db3\u6574\u7247\u7684\u6eb6\u51fa\u5ea6\u8981\u6c42\u3002<\/span><\/p>\n


    <\/span><\/p>\n

    \u7f13\u91ca\u5236\u5242\u7b49\u5176\u4ed6\u4fee\u9970\u5236\u5242<\/span><\/strong><\/span><\/p>\n

      \n
    1. \n

      \u9700\u6ee1\u8db3\u6ee1\u8db3\u56fa\u4f53\u53e3\u670d\u901f\u91ca\u5236\u5242\u7684\u6280\u672f\u8981\u6c42\uff1b<\/span><\/p>\n<\/li>\n

    2. \n

      \u5e94\u5728\u786c\u5ea6\u4e0a\u9650\u548c\u4e0b\u9650\u5904\u5206\u522b\u53d6\u6837\u68c0\u6d4b\u6eb6\u51fa\u5ea6\uff0c\u6ee1\u8db3\u6eb6\u51fa\u5ea6\u63a5\u53d7\u6807\u51c6\uff1b<\/span><\/p>\n<\/li>\n

    3. \n

      \u63b0\u7247\u7684\u534a\u7247\u836f\u7269\u5e94\u8fdb\u884c\u6eb6\u51fa\u66f2\u7ebf\u6d4b\u5b9a\uff0c\u5e76\u4e0e\u6574\u7247\u7684\u6eb6\u51fa\u66f2\u7ebf\u6bd4\u8f83\uff0c\u8ba1\u7b97<\/span>f2<\/span>\u76f8\u4f3c\u56e0\u5b50\uff0c\u4e14\u7b26\u5408\u8981\u6c42\uff08<\/span>f2<\/span>\u2265<\/span>50<\/span>\uff09\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


      <\/p>\n

      \u5fae\u4e38\u538b\u7247\u6280\u672f<\/span><\/strong><\/span><\/p>\n

        \n
      1. \n

        \u5e94\u6ee1\u8db3\u56fa\u4f53\u53e3\u670d\u901f\u91ca\u5236\u5242\u548c\u7f13\u91ca\u5236\u5242\u7684\u6280\u672f\u8981\u6c42\uff1b<\/span><\/strong><\/p>\n<\/li>\n

      2. \n

        \u5e94\u6ee1\u8db3<\/span><\/strong>\u538b\u7247\u524d\u7684\u5fae\u4e38\u4e0e\u538b\u7247\u540e\u7684\u6574\u7247\u3001\u63b0\u7247\u540e\u7684\u534a\u7247\u6eb6\u51fa\u66f2\u7ebf\u5e94\u6ee1\u8db3<\/span>f2<\/span>\u76f8\u4f3c\u56e0\u5b50\u6807\u51c6\uff0c\u4ee5\u786e\u4fdd\u534a\u7247\u7684\u91ca\u653e\u60c5\u51b5\u4e0d\u53d1\u751f\u6539\u53d8\u3002<\/span><\/p>\n<\/li>\n

      3. \n

        \u4eff\u5236\u836f\u54c1\u7684\u523b\u75d5\u5916\u89c2\u5e94\u4e0e\u53c2\u6bd4\u5236\u5242\u4e00\u81f4\u3002\u5f53\u836f\u7269\u7684\u523b\u75d5\u6536\u4e13\u5229\u4fdd\u62a4\u65f6\uff0c\u8bf7\u8054\u7cfb\u4eff\u5236\u836f\u529e\u516c\u5ba4\uff1b\u5f53\u836f\u7269\u7684\u523b\u75d5\u6709\u5408\u7406\u7684\u7406\u7531\u7701\u7565\u65f6\uff0c\u8bf7\u8054\u7cfb\u4eff\u5236\u836f\u529e\u516c\u5ba4\u3002<\/span><\/p>\n<\/li>\n<\/ol>\n


        <\/span><\/p>\n

        \u4ea7\u54c1\u547d\u540d\u548c\u4ea7\u54c1\u6807\u7b7e<\/span><\/strong><\/span><\/p>\n

        \u65b0\u4ea7\u54c1\uff08\u5373\u65b0\u836f\uff09\u5177\u6709\u529f\u80fd\u6027\u523b\u75d5\u65f6\uff08\u5373\u7528\u4e8e\u63b0\u7247\uff09\uff0c\u5e94\u6ee1\u8db3\u4e0a\u9762\u7684\u6807\u51c6\u3002\u8fd9\u6837\u7684\u6807\u793a\u4fe1\u606f\u5e94\u8be5\u51fa\u73b0\u5728\u5904\u65b9\u4fe1\u606f\u4e2d\uff1a<\/span><\/p>\n

          \n
        1. \n

          \u5e94\u5728\u5242\u578b\u548c\u89c4\u683c\u7684\u90e8\u5206\u8bf4\u660e\uff1b<\/span><\/p>\n<\/li>\n

        2. \n

          \u5242\u578b\u548c\u89c4\u683c\u7684\u90e8\u5206\u63d0\u4f9b\u5168\u90e8\u5904\u65b9\u4fe1\u606f\uff1b<\/span><\/p>\n<\/li>\n

        3. \n

          \u8fd0\u8f93\u7684\u90e8\u5206\u63d0\u4f9b\u5168\u90e8\u5904\u65b9\u3002<\/span><\/p>\n


          <\/p>\n<\/li>\n<\/ol>\n

          \u8fd9\u4e9b\u4fe1\u606f\u4e5f\u5e94\u8be5\u5305\u62ec\u5728\u60a3\u8005\u8bf4\u660e\u4e66\u548c\u533b\u5b66\u6307\u5357\u91cc\u9762\u3002\u4e0d\u7b26\u5408\u8fd9\u4e2a\u6807\u51c6\u7684\u65b0\u4ea7\u54c1\u5c06\u4e0d\u88ab<\/span>FDA<\/span>\u6279\u51c6\uff0c\u4e0d\u5e94\u542b\u6709\u523b\u75d5\u7279\u5f81\uff0c\u4e5f\u4e0d\u5e94\u8be5\u5728\u8bf4\u660e\u4e66\u7b49\u91cc\u9762\u63d0\u5230\u523b\u75d5\u4fe1\u606f<\/span>(<\/span>\u5305\u62ec\u8bed\u53e5\uff0c\u4f8b\u5982\u5e73\u5206\u7b49<\/span>)<\/span>\u3002<\/span><\/p>\n


          <\/span><\/p>\n

          \u6700\u540e\uff0c\u5c0f\u7f16\u89c9\u5f97\u5982\u679c\u7247\u5242\u7684\u523b\u75d5\u662f\u4e3a\u4e86\u62c6\u5206\u5242\u91cf\uff0c\u5219\u9700\u8fdb\u884c\u534a\u7247\u76f8\u5173\u7814\u7a76\uff0c\u5982\u679c\u662f\u56e0\u4e3a\u7247\u5242\u4f53\u79ef\u8f83\u5927\uff0c\u4e0d\u6613\u541e\u670d\uff0c\u5219\u5e94\u4e0d\u9700\u8981\u8fdb\u884c\u534a\u7247\u7814\u7a76\u3002\u5c0f\u7f16\u60f3\u8d77\u5c0f\u65f6\u5019\uff0c\u5934\u75bc\u6216\u53d1\u70ed\u6216\u5176\u4ed6\uff0c\u8001\u5bb6\u8bca\u6240\u533b\u751f\u4f1a\u7ed9\u914d\u4e00\u5c0f\u5305\u836f\uff0c\u8bb0\u5f97\u5f88\u591a\u65f6\u5019\u5927\u836f\u7247\u90fd\u7ed9\u63b0\u6210\u534a\u7247\uff0c\u5f53\u65f6\u89c9\u5f97\u5c31\u662f\u4e3a\u4e86\u80fd\u54bd\u4e0b\u53bb\uff0c\u73b0\u5728\u60f3\u60f3\u4e5f\u8bb8\u662f\u6210\u4eba\u836f\u800c\u975e\u513f\u7ae5\u7528\u836f\u3002\u4e0d\u8fc7\u73b0\u5728\u533b\u836f\u884c\u4e1a\u7684\u8fc5\u901f\u53d1\u5c55\uff0c\u73b0\u5728\u513f\u7ae5\u7528\u836f\u6bd4<\/span>80<\/span>\u3001<\/span>90<\/span>\u5e74\u4ee3\u51fa\u751f\u7684\u513f\u7ae5\u6240\u7528\u7684\u836f\u54c1\u5b89\u5168\u591a\u4e86\u3002<\/span><\/p>\n


          <\/span><\/p>\n

          \u672c\u6587\u4ec5\u4ee3\u8868\u4e2a\u4eba\u89c2\u70b9\uff0c\u6b22\u8fce\u5927\u5bb6\u8ba8\u8bba\u548c\u6307\u6b63\uff01<\/span><\/p>\n


          <\/span><\/p>\n

          \u53c2\u8003\u6587\u732e\uff1a<\/span><\/p>\n

          Guidancefor industry  Tablets scoring:Numenclature, Labeling, and Data for evaluation.<\/span><\/p>\n


          <\/span><\/p>\n

          —-END—-<\/span><\/p>\n


          <\/p>\n

          \n


          <\/p>\n

          \u6392\u7248\uff1aSUNRISE<\/span>
          <\/p>\n

          \n
          \n
          \n
          \u5e7f\u800c\u544a\u4e4b<\/section>\n<\/section>\n<\/section>\n
          \n
          \n

          \u2299 \u540c\u5199\u610f\u57f9\u8bad<\/span><\/p>\n

          \u5199\u610f\u8bba\u575b\u4e28\u65b0\u836f\u4e2d\u7f8e\u53cc\u62a5\u4e4b\u5236\u5242\u6eb6\u51fa\u6280\u672f\u5f00\u53d1<\/a><\/span><\/p>\n

          \u5199\u610f\u8bba\u575b\u4e28\u56fd\u9645\u89c4\u8303\u4e0b\u751f\u7269\u836f\u5168\u751f\u547d\u5468\u671f\u8d28\u91cf\u7ba1\u7406<\/a><\/span><\/p>\n

          \u5199\u610f\u516c\u76ca\u4e28\u4eff\u5236\u836f\u4e00\u81f4\u6027\u8bc4\u4ef7\u5927\u76d8\u70b9\u4e0e\u603b\u51b3\u6218<\/a><\/p>\n

          \u6ee1\u8db3IND\/NDA\u4e2d\u7f8e\u53cc\u62a5\u7684\u53e3\u670d\u65b0\u836f\u5236\u5242\u7814\u53d1<\/a><\/span><\/p>\n<\/section>\n<\/section>\n<\/section>\n

          \n
          \n
          \n

          <\/section>\n<\/section>\n<\/section>\n<\/section>\n


          <\/p>\n

          \n

          \"FDA\u5173\u4e8e\u523b\u75d5\u7247\u7814\u7a76\u7684\u8981\u6c42\u548c\u5efa\u8bae\"<\/p>\n

          \u836f\u4e8b\u7eb5\u6a2a\u662f\u4e00\u4e2a\u5f00\u653e\uff0c\u7531\u81ea\u613f\u8005\u7ec4\u6210\u7684\u56e2\u4f53\uff0c\u73b0\u6709\u6210\u545838\u540d\uff0c\u5206\u522b\u4e3aVoyager88\uff08\u9b4f\u5229\u519b\uff09\uff0c\u96f7\u8bfa\u5c9b\uff0c\u4e09\u5206\u8bdd\uff0cHerman\uff0c\u6885\u5e0c\uff0c\u6587\u7af9\uff0cduke\uff0cyhqqqqq\uff0c\u5360\u5c0f\u5175\uff0c\u98ce\u4e00\u6837\u7684\u5c4e\u58f3\u90ce\uff0c\u9526\u5fc3\u7ee3\u53e3\uff0cflydp511\uff0c\u5de7\u5de7\uff0c\u4e91\u6c34\u9053\u4eba\uff0c\u9621\u4e0a\u964c\u964c\uff0c\u591a\u5df4\u80fa\uff0c\u745c\u513f\uff0cKailyn\uff0cSmall fish\uff0c\u5b50\u708e\uff0c\u514b\u683c\u83ab\uff0cVicky\uff0cPandada\uff0c\u83ab\u5306\u5306\uff0cSophia \uff0c\u4f9d\u7136\u7279\u96f7\u897f\uff0c\u5076\u9635\u96e8\uff0cAimee\uff0c\u4ed6\u5c71\u4e4b\u77f3\uff0c\u5510\u5c0f\u7396\uff0c\u96f6\u4e0b274\u2103\uff0cGloria\uff0cBreathless\uff0cLuffy\uff0c\u80e1\u4e0d\u559c\uff0c Helen\uff0c\u843d\u843d\uff0cSUNRISE\u3002\u6b22\u8fce\u6709\u5fd7\u4e4b\u58eb\u52a0\u5165\u6211\u4eec\u56e2\u961f\u3002\u6295\u7a3f\u3001\u5408\u4f5c\u3001\u52a0\u4e13\u4e1a\u7fa4\u8bf7\u52a0\u5fae\u4fe1442015666\uff0c\u836f\u4e8b\u7eb5\u6a2a\u4e8c\u5343\u4ebaQQ\u7fa422711855\u3002<\/span>
          <\/p>\n

          \n

          \u59cb\u53d1\u4e8e\u5fae\u4fe1\u516c\u4f17\u53f7\uff1a \u836f\u4e8b\u7eb5\u6a2a <\/p>\n<\/blockquote>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

          \u8ba8\u8bba\uff1a\u5c0f\u7f16\u6700\u8fd1\u6240\u5728\u516c\u53f8\u6709\u4e00\u4ea7\u54c1\u8fdb\u884cFDA\u6ce8\u518c\u7533\u62a5\uff0c\u5206\u522b\u67092.5mg\u30015mg\u300110mg\uff0c\u4f465mg\u4e3a\u523b\u75d5\u7247\uff0c\u6309\u7167F […]<\/p>\n","protected":false},"author":1,"featured_media":19938,"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\/19937"}],"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=19937"}],"version-history":[{"count":1,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/19937\/revisions"}],"predecessor-version":[{"id":19943,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/posts\/19937\/revisions\/19943"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media\/19938"}],"wp:attachment":[{"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/media?parent=19937"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/categories?post=19937"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.05921.net\/index.php\/wp-json\/wp\/v2\/tags?post=19937"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}