{"id":40764,"date":"2019-08-08T10:24:38","date_gmt":"2019-08-08T14:24:38","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-announces-new-medical-device-generic-drug-and-human-drug-compounding-user-fees-for-fy-2020\/"},"modified":"2020-02-07T18:34:08","modified_gmt":"2020-02-07T18:34:08","slug":"fda-announces-new-medical-device-generic-drug-and-human-drug-compounding-user-fees-for-fy-2020","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-announces-new-medical-device-generic-drug-and-human-drug-compounding-user-fees-for-fy-2020\/","title":{"rendered":"FDA\u516c\u5e03\u533b\u7597\u5668\u68b0\u3001\u4eff\u5236\u836f\u53ca\u4eba\u7528\u836f\u7269\u5408\u62102020\u8d22\u5e74\u7684\u5b98\u65b9\u8d39\u7528"},"content":{"rendered":"

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2020\u8d22\u5e74GDUFA\u8d39\u7528\u4e00\u89c8\u8868<\/strong><\/p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
\u8d39\u7528\u7c7b\u522b<\/strong><\/td>\r\n2020 \u8d22\u5e74\u8d39\u7528<\/strong><\/td>\r\n<\/tr>\r\n
\u4f01\u4e1a\u7c7b\u578b<\/strong><\/td>\r\n\u00a0 \u56fd\u5185<\/strong><\/td>\r\n\u56fd\u5916<\/strong><\/td>\r\n<\/tr>\r\n
\u6d3b\u6027\u836f\u7269\u6210\u5206 \u00a0 \u00a0<\/td>\r\n$44,400<\/td>\r\n$59,400<\/td>\r\n<\/tr>\r\n
\u5236\u5242<\/td>\r\n$195,662<\/td>\r\n$210,662<\/td>\r\n<\/tr>\r\n
\u5408\u540c\u52a0\u5de5\u5916\u5305CMO<\/td>\r\n$65,221<\/td>\r\n$80,221<\/td>\r\n<\/tr>\r\n
\u7533\u8bf7\u7c7b\u578b<\/strong><\/td>\r\n<\/tr>\r\n
\u7b80\u7565\u65b0\u836f\u7533\u8bf7\uff08ANDA\uff09<\/td>\r\n$176,237<\/td>\r\n<\/tr>\r\n
\u836f\u7269\u7ba1\u7406\u6863\u6848\uff08DMF\uff09<\/td>\r\n$57,795<\/td>\r\n<\/tr>\r\n
\u7b80\u7565\u65b0\u836f\u7533\u8bf7\u9879\u76ee\u8d39\u7528<\/strong><\/td>\r\n<\/tr>\r\n
\u5927\u578b\uff0820\u4e2a\u6216\u4ee5\u4e0a\uff09<\/td>\r\n$1,661,684<\/td>\r\n<\/tr>\r\n
\u4e2d\u578b\uff086-19\u4e2a\uff09<\/td>\r\n$664,674<\/td>\r\n<\/tr>\r\n
\u5c0f\u578b\uff085\u4e2a\u6216\u66f4\u5c11\uff09<\/td>\r\n$166,168<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n\r\n\r\n\r\n

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2020\u8d22\u5e74\u5916\u5305\u578b\u4f01\u4e1a\u8d39\u7528<\/strong><\/p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
\u8d39\u7528\u7c7b\u522b<\/strong><\/td>\r\n2020 \u8d22\u5e74\u8d39\u7528<\/strong><\/td>\r\n<\/tr>\r\n
\u5408\u683c\u7684\u5c0f\u578b\u4f01\u4e1a \u00a0<\/td>\r\n$5,599<\/td>\r\n<\/tr>\r\n
\u975e\u5c0f\u578b\u4f01\u4e1a<\/td>\r\n$18,288<\/td>\r\n<\/tr>\r\n
\u4e8c\u6b21\u9a8c\u5382<\/td>\r\n$16,798<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n\r\n\r\n\r\n

\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u8d39\u7528<\/strong><\/p>\r\n\r\n\r\n\r\n

FDA\u8981\u6c42\u67d0\u4e9b\u7c7b\u578b\u7684\u533b\u7597\u5668\u68b0\u7533\u8bf7\uff0cIII\u7c7b\u533b\u7597\u5668\u68b0\u7684\u5b9a\u671f\u62a5\u544a\uff0c\u4ee5\u53ca\u4f01\u4e1a\u5e74\u5ea6\u6ce8\u518c\u9700\u8981\u7f34\u7eb3\u8d39\u7528\u3002\u6700\u8fd1\u4e00\u4e2a\u8d22\u5e74\u7684\u5e74\u9500\u552e\u989d\u4e0d\u8d85\u8fc7\u4e00\u4ebf\u7f8e\u5143\u7684\u4f01\u4e1a\u53ef\u4ee5\u5411FDA\u7533\u8bf7\u4eab\u53d7\u201c\u5c0f\u578b\u4f01\u4e1a\u201d\u51cf\u514d\u3002\u5e74\u9500\u552e\u989d\u5c0f\u4e8e\u4e09\u5343\u4e07\u7f8e\u5143\u7684\u4f01\u4e1a\u9996\u6b21\u9012\u4ea4\u4e0a\u5e02\u524d\u6279\u51c6\u6216\u8005\u5b9a\u671f\u62a5\u544a\u65f6\u53ef\u4ee5\u7533\u8bf7\u8c41\u514d\u8d39\u7528\u3002\u82e5\u8d35\u53f8\u57282019\u8d22\u5e74\u7533\u8bf7\u4e86\u5c0f\u4f01\u4e1a\u4f18\u60e0\u6216\u8005\u51cf\u514d\uff0c\u8d35\u53f8\u9700\u8981\u5728\u66f4\u65b0\u671f\u95f4\u518d\u6b21\u5411FDA\u9012\u4ea4\u51cf\u514d\u7533\u8bf7\u4ee5\u786e\u4fdd\u8d35\u53f8\u4ecd\u7136\u7b26\u5408\u51cf\u514d\u8d44\u8d28\u3002<\/p>\r\n\r\n\r\n\r\n

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2020\u8d22\u5e74MDUFA\u8d39\u7528<\/strong><\/p>\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n\r\n
\u8d39\u7528\u7c7b\u522b<\/strong><\/td>\r\n2020\u8d22\u5e74\u8d39\u7528<\/strong><\/td>\r\n<\/tr>\r\n
\u4f01\u4e1a\u6ce8\u518c\u5e74\u8d39<\/td>\r\n$5,236<\/td>\r\n<\/tr>\r\n
\u7533\u8bf7\u7c7b\u522b<\/strong><\/td>\r\n\u6807\u51c6\u8d39\u7528<\/strong><\/td>\r\n\u5c0f\u4f01\u4e1a\u8d39\u7528<\/strong><\/td>\r\n<\/tr>\r\n
\u5c0f\u7ec4\u8ddf\u8e2a\u8865\u5145 \u00a0<\/td>\r\n$255,747<\/td>\r\n$63,937<\/td>\r\n<\/tr>\r\n
\u91cd\u65b0\u5206\u7c7b<\/td>\r\n$102,299<\/td>\r\n$25,575<\/td>\r\n<\/tr>\r\n
180\u5929\u8865\u5145\u62a5\u544a<\/td>\r\n$51,149<\/td>\r\n$12,787<\/td>\r\n<\/tr>\r\n
\u5b9e\u65f6\u8865\u5145\u62a5\u544a<\/td>\r\n$23,870<\/td>\r\n$5,968<\/td>\r\n<\/tr>\r\n
510(k)s \u00a0<\/td>\r\n$11,594<\/td>\r\n$2,899<\/td>\r\n<\/tr>\r\n
513(g)<\/td>\r\n$4,603<\/td>\r\n$2,302<\/td>\r\n<\/tr>\r\n
30\u5929\u901a\u544a<\/td>\r\n$5,456<\/td>\r\n$2,728<\/td>\r\n<\/tr>\r\n
PMA\u5e74\u5ea6\u62a5\u544a<\/td>\r\n$11,935<\/td>\r\n$2,984<\/td>\r\n<\/tr>\r\n
PMA, PDP, PMR, BLA \u00a0 \u00a0<\/td>\r\n$340,995<\/td>\r\n$85,249<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n\r\n\r\n\r\n

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