{"id":51448,"date":"2021-08-05T10:13:22","date_gmt":"2021-08-05T14:13:22","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022\/"},"modified":"2021-08-17T15:49:48","modified_gmt":"2021-08-17T19:49:48","slug":"fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/jp\/fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022\/","title":{"rendered":"FDA\u304c2022\u5e74\u5ea6\u306b\u5411\u3051\u305f\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u5f8c\u767a\u54c1\u306e\u65b0\u305f\u306a\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u3092\u767a\u8868"},"content":{"rendered":"

FDA\u306f\u3001\u5f8c\u767a\u54c1\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u306e\u6539\u6b63\uff08GDUFA\uff09\u3068\u533b\u85ac\u54c1\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u306e\u6539\u6b63\uff08MDUFA\uff09\u3092\u3082\u3068\u306b\u30012022\u5e74\u5ea6\u306e\u65b0\u305f\u306a\u30d5\u30a3\u30fc\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002<\/p>\n

\u65b0\u5e74\u5ea6\u306f2021\u5e7410\u67081\u65e5\u304b\u30892022\u5e749\u670830\u65e5\u307e\u3067\u306e1\u5e74\u9593\u3067\u3059\u3002\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u65bd\u8a2d\u306fFDA\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3053\u306e\u30d5\u30a3\u30fc\u304c\u8ab2\u305b\u3089\u308c\u307e\u3059\u3002<\/p>\n

\u533b\u85ac\u54c1\u65bd\u8a2d\u306b\u8ab2\u305b\u3089\u308c\u308b\u30d5\u30a3\u30fc<\/strong><\/p>\n

FDA \u306fGDUFA\u306b\u57fa\u3065\u304d\u3001API\uff08\u539f\u85ac\uff09\u65bd\u8a2d\u3001FDF\u65bd\u8a2d\u3001\u533b\u85ac\u54c1\u88fd\u9020\u53d7\u8a17\u6a5f\u95a2\uff08CMO\uff09\u306e\u30d5\u30a3\u30fc\u3092\u67fb\u5b9a\u3057\u3001\u5fb4\u53ce\u3057\u307e\u3059\u3002\u7c73\u56fd\u5916\u306e\u65bd\u8a2d\u306b\u8ab2\u305b\u3089\u308c\u308b\u30d5\u30a3\u30fc\u306f\u691c\u67fb\u306b\u304b\u304b\u308b\u8ffd\u52a0\u8cbb\u7528\u3092\u88dc\u511f\u3059\u308b\u305f\u3081\u306b\u9ad8\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n

GDUFA\u306b\u57fa\u3065\u304f\u65bd\u8a2d\u306e\u30d5\u30a3\u30fc\u306f\u30012020\u5e74\u304b\u30892021\u5e74\u306b\u304b\u3051\u3066\u306e\u6e1b\u984d\u3068\u306f\u5bfe\u7167\u7684\u306b\u3001\u5897\u984d\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u5185\u304a\u3088\u3073\u7c73\u56fd\u5916\u306eAPI\u30d5\u30a3\u30fc\u306f\u7d042\uff05\u3001FDF\u65bd\u8a2d\u304a\u3088\u3073CMO\u306e\u30d5\u30a3\u30fc\u306f\u7d045\uff05\u4e0a\u6607\u3057\u3066\u3044\u307e\u3059\u3002\u4e00\u65b9\u3067\u3001\u30d7\u30ed\u30b0\u30e9\u30e0\u30d5\u30a3\u30fc\u306f\u4e8b\u696d\u8005\u306e\u898f\u6a21\u3092\u554f\u308f\u305a\u7d040.4\uff05\u4f4e\u4e0b\u3057\u307e\u3057\u305f\u3002<\/p>\n

\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u306e\u4e0a\u6607\u306f\u3001\u304a\u305d\u3089\u304f\u6700\u7d42\u8abf\u6574\u306b\u8d77\u56e0\u3059\u308b\u3082\u306e\u3067\u3001\u3053\u308c\u306b\u3088\u3063\u3066FDA\u306f\u6700\u5927\u30673\u304b\u6708\u5206\u306e\u4e8b\u696d\u6d3b\u52d5\u306b\u76f8\u5f53\u3059\u308b\u6e96\u5099\u91d1\u3092\u78ba\u4fdd\u3059\u308b\u3053\u3068\u306b\u306a\u308a\u307e\u3059\u3002\u540c\u6642\u306b\u3053\u306e\u6e96\u5099\u91d1\u306f2023\u5e74\u5ea6\u521d\u3081\u306b\u4f01\u753b\u3055\u308c\u3066\u3044\u308b\u30b8\u30a7\u30cd\u30ea\u30c3\u30af\u533b\u85ac\u54c1\u306b\u95a2\u3059\u308b\u6d3b\u52d5\u8cbb\u3092\u88dc\u3046\u4e88\u5b9a\u3067\u3059\u3002\u8abf\u6574\u3092\u898b\u6975\u3081\u308b\u305f\u3081\u3001FDA\u306f\u4e88\u5b9a\u3055\u308c\u3066\u3044\u308b\u5fb4\u53ce\u984d\u3068\u50b5\u52d9\u3092\u5206\u6790\u3057\u3001\u30d5\u30a3\u30fc\u306e\u4e0a\u6607\u306b\u3088\u3063\u3066\u696d\u754c\u306b\u53ca\u307c\u3059\u8ca1\u653f\u8ca0\u62c5\u3092\u691c\u8a0e\u3057\u307e\u3057\u305f\u3002\u6700\u7d42\u7684\u306b\u3001FDA\u306f\uff17\u9031\u9593\u5206\u306e\u4e8b\u696d\u6d3b\u52d5\u306b\u5145\u3066\u308b\u6e96\u5099\u91d1\u3092\u78ba\u4fdd\u3059\u308b\u305f\u3081\u306b\u30d5\u30a3\u30fc\u306e\u5897\u984d\u3092\u6c7a\u5b9a\u3057\u307e\u3057\u305f\u3002<\/p>\n

2022 \u5e74\u5ea6\u306eGDUFA\u306b\u3088\u308b \u30d5\u30a3\u30fc<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u30d5\u30a3\u30fc\u306e\u7a2e\u985e<\/strong><\/td>\n2021\u5e74\u5ea6<\/strong><\/td>\n2022\u5e74\u5ea6<\/strong><\/td>\n<\/tr>\n
\u65bd\u8a2d\u30d5\u30a3\u30fc<\/strong><\/td>\n\u7c73\u56fd\u5185<\/strong><\/td>\n\u7c73\u56fd\u5916<\/strong><\/td>\n\u7c73\u56fd\u5185<\/strong><\/td>\n\u7c73\u56fd\u5916<\/strong><\/td>\n<\/tr>\n
API\u65bd\u8a2d<\/td>\n$41,671<\/td>\n$56,671<\/td>\n$42,557<\/td>\n$57,557<\/td>\n<\/tr>\n
FDF\u65bd\u8a2d<\/td>\n$184,022<\/td>\n$199,022<\/td>\n$195,012<\/td>\n$210,012<\/td>\n<\/tr>\n
Contract Manufacturing Organization (CMO)<\/td>\n$61,341<\/td>\n$76,341<\/td>\n$65,004<\/td>\n$80,004<\/td>\n<\/tr>\n
GDUFA \u306b\u3088\u308b\u30d7\u30ed\u30b0\u30e9\u30e0\u30d5\u30a3\u30fc\uff1a\u627f\u8a8d\u3055\u308c\u305fANDA\uff08\u7c21\u6613\u65b0\u85ac\u627f\u8a8d\u7533\u8acb\uff09\u306e\u6570\u306b\u57fa\u3065\u304f<\/strong><\/td>\n<\/tr>\n
\u5927\u898f\u6a21 (ANDA20\u4ef6\u4ee5\u4e0a)<\/td>\n$1,542,993<\/td>\n$1,536,856<\/td>\n<\/tr>\n
\u4e2d\u898f\u6a21 (ANDA6\u301c19\u4ef6)<\/td>\n$617,197<\/td>\n$614,742<\/td>\n<\/tr>\n
\u5c0f\u898f\u6a21 (ANDA5\u4ef6\u4ee5\u4e0b)<\/td>\n$154,299<\/td>\n$153,686<\/td>\n<\/tr>\n
\u7533\u8acb\u30d5\u30a3\u30fc<\/strong><\/td>\n<\/tr>\n
ANDA<\/td>\n$196,868<\/td>\n$225,712<\/td>\n<\/tr>\n
\u30bf\u30a4\u30d7 II DMF<\/td>\n$69,921<\/td>\n$74,952<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

\u533b\u7642\u6a5f\u5668\u65bd\u8a2d\u306b\u8ab2\u305b\u3089\u308c\u308b\u30d5\u30a3\u30fc<\/strong><\/p>\n

FDA\u306f\u3001\u7279\u5b9a\u306e\u533b\u7642\u6a5f\u5668\u7533\u8acb\u3001\u30af\u30e9\u30b9\u2162\u306b\u5206\u985e\u3055\u308c\u308b\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u5b9a\u671f\u5831\u544a\u3001\u4e8b\u696d\u8005\u306e\u5e74\u9593\u767b\u9332\u306b\u30d5\u30a3\u30fc\u306e\u652f\u6255\u3044\u3092\u7fa9\u52d9\u4ed8\u3051\u3066\u3044\u307e\u3059\u3002\u76f4\u8fd1\u306e\u4f1a\u8a08\u5e74\u5ea6\u306b\u304a\u3051\u308b\u7dcf\u58f2\u4e0a\u304c1\u5104\u30c9\u30eb\u672a\u6e80\u306e\u4e8b\u696d\u8005\u306f\u5c0f\u898f\u6a21\u4e8b\u696d\u8005\u3068\u3057\u3066\u7533\u8acb\u306b\u95a2\u3059\u308b\u8cbb\u7528\u304c\u6e1b\u984d\u3055\u308c\u307e\u3059\u3002\u307e\u305f\u3001\u7dcf\u58f2\u4e0a3,000\u4e07\u30c9\u30eb\u672a\u6e80\u306e\u4e8b\u696d\u8005\u306f\u521d\u56de\u306ePMA(\u5e02\u8ca9\u524d\u627f\u8a8d)\u307e\u305f\u306f\u5831\u544a\u304c\u514d\u9664\u3055\u308c\u307e\u3059\u30022021\u5e74\u5ea6\u306b\u6e1b\u984d\u307e\u305f\u306f\u514d\u9664\u306e\u5bfe\u8c61\u3068\u306a\u3063\u305f\u4e8b\u696d\u8005\u304c\u5f15\u304d\u7d9a\u304d\u305d\u306e\u8cc7\u683c\u3092\u7dad\u6301\u3059\u308b\u306b\u306f\u66f4\u65b0\u671f\u9593\u4e2d\u306b\u4e8b\u696d\u306b\u95a2\u3059\u308b\u5fc5\u8981\u66f8\u985e\u3092\u518d\u5ea6FDA\u306b\u63d0\u51fa\u3057\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u3002<\/p>\n

\u5c0f\u898f\u6a21\u4e8b\u696d\u8005\u306f\u3001\u65bd\u8a2d\u767b\u9332\u306e\u8cbb\u7528\u306f\u63a7\u9664\u3055\u308c\u307e\u305b\u3093\u3002\u65bd\u8a2d\u767b\u9332\u306f\u3059\u3079\u3066\u306e\u4e8b\u696d\u8005\u306b\u5bfe\u3057\u3066\u4e00\u5b9a\u3067\u3001FDA\u306f\u652f\u6255\u304c\u6e08\u3080\u307e\u3067\u767b\u9332\u5b8c\u4e86\u3068\u307f\u306a\u3057\u307e\u305b\u3093\u3002\u307e\u305f\u3001\u3053\u306e\u30d5\u30a3\u30fc\u306f\u3001\u5f53\u8a72\u4e8b\u696d\u8005\u304c\u6240\u6709\u3057\u3001\u533b\u7642\u6a5f\u5668\u306b\u95a2\u3059\u308b\u4e00\u5b9a\u306e\u6a5f\u80fd\u3092\u6709\u3059\u308b\u3059\u3079\u3066\u306e\u62e0\u70b9\u306b\u9069\u7528\u3055\u308c\u308b\u305f\u3081\u3001\u62e0\u70b9\u3054\u3068\u306b\u65bd\u8a2d\u30d5\u30a3\u30fc\u3092\u652f\u6255\u308f\u306a\u3051\u308c\u3070\u306a\u308a\u307e\u305b\u3093\u30022022\u5e74\u5ea6\u306e\u30d5\u30a3\u30fc\u306f2021\u5e74\u5ea6\u306b\u6bd4\u3079\u3066\u7d042.5\uff05\u4e0a\u6607\u3057\u3066\u3044\u307e\u3059\u3002FDA \u306f\u53bb\u5e74\u306e\u30a4\u30f3\u30d5\u30ec\u3092\u4e0a\u6607\u306e\u4e3b\u8981\u56e0\u3068\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n

2022 \u5e74\u5ea6\u306eMDUFA \u306b\u3088\u308b\u30d5\u30a3\u30fc<\/strong><\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u30d5\u30a3\u30fc\u306e\u7a2e\u985e<\/strong><\/td>\n2021<\/strong><\/td>\n2022<\/strong><\/td>\n<\/tr>\n
\u5e74\u9593\u65bd\u8a2d\u767b\u9332<\/td>\n$5,546<\/td>\n$5,672<\/td>\n<\/tr>\n
\u7533\u8acb\u30d5\u30a3\u30fc<\/strong><\/td>\n\u4e00\u822c<\/strong><\/td>\n\u5c0f\u898f\u6a21\u4e8b\u696d\u8005<\/strong><\/td>\n\u4e00\u822c<\/strong><\/td>\n\u5c0f\u898f\u6a21\u4e8b\u696d\u8005<\/strong><\/td>\n<\/tr>\n
510(k)\uff08\u5e02\u8ca9\u524d\u901a\u77e5<\/td>\n$12,432<\/td>\n$3,108<\/td>\n$12,745<\/td>\n$3,186<\/td>\n<\/tr>\n
513(g)\u8981\u8acb<\/td>\n$4,936<\/td>\n$2,468<\/td>\n$5,061<\/td>\n$2,530<\/td>\n<\/tr>\n
De Novo \u7533\u8acb<\/td>\n$109,697<\/td>\n$27,424<\/td>\n$112,457<\/td>\n$28,114<\/td>\n<\/tr>\n
PMA\u3001PDP\u3001PMR\u3001BLA<\/td>\n$365,657<\/td>\n$91,414<\/td>\n$374,858<\/td>\n$93,714<\/td>\n<\/tr>\n
panel-track supplement<\/td>\n$274,243<\/td>\n$68,561<\/td>\n$281,143<\/td>\n$70,286<\/td>\n<\/tr>\n
180-day supplement<\/td>\n$54,849<\/td>\n$13,712<\/td>\n$56,229<\/td>\n$14,057<\/td>\n<\/tr>\n
real-time supplement<\/td>\n$25,596<\/td>\n$6,399<\/td>\n$26,240<\/td>\n$6,560<\/td>\n<\/tr>\n
BLA efficacy supplement<\/td>\n$365,657<\/td>\n$91,414<\/td>\n$374,858<\/td>\n$93,714<\/td>\n<\/tr>\n
PMA \u5e74\u6b21\u5831\u544a\u66f8<\/td>\n$12,798<\/td>\n$3,200<\/td>\n$13,120<\/td>\n$3,280<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Registrar\u793e\u306f\u3001FDA\u898f\u5247\u306e\u9075\u5b88\u3092\u652f\u63f4\u3059\u308b\u4f01\u696d\u3067\u3059\u3002\u8cb4\u793e\u306e\u30d5\u30a3\u30fc\u306e\u78ba\u8a8d\u304b\u3089FDA\u3078\u306e\u652f\u6255\u3044\u307e\u3067\u3092\u30b5\u30dd\u30fc\u30c8\u3044\u305f\u3057\u307e\u3059\u3002\u8a73\u7d30\u306f\u304a\u96fb\u8a71\uff08+1-757-224-0177\uff09\u307e\u305f\u306f\u30e1\u30fc\u30eb\uff08info@registrarcorp.com<\/a>\uff09\u306b\u3066\u304a\u554f\u3044\u5408\u308f\u305b\u304f\u3060\u3055\u3044\u3002\u5c02\u9580\u5bb6\u306b\u3088\u308b\u30c1\u30e3\u30c3\u30c8\uff08regstaging.wpengine.com\/livechat<\/a>\uff09\u308224\u6642\u9593\u3054\u5229\u7528\u3044\u305f\u3060\u3051\u307e\u3059\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"

FDA\u306f\u3001\u5f8c\u767a\u54c1\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u306e\u6539\u6b63\uff08GDUFA\uff09\u3068\u533b\u85ac\u54c1\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u306e\u6539\u6b63\uff08MDUFA\uff09\u3092\u3082\u3068\u306b\u30012022\u5e74\u5ea6\u306e\u65b0\u305f\u306a\u30d5\u30a3\u30fc\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002 \u65b0\u5e74\u5ea6\u306f2021\u5e7410\u67081\u65e5\u304b\u30892022\u5e749\u670830\u65e5\u307e\u3067\u306e1\u5e74\u9593\u3067\u3059\u3002\u533b\u85ac\u54c1\u304a\u3088\u3073\u533b\u7642\u6a5f\u5668\u65bd\u8a2d\u306fFDA\u306e\u30b3\u30f3\u30d7\u30e9\u30a4\u30a2\u30f3\u30b9\u3092\u7dad\u6301\u3059\u308b\u305f\u3081\u306b\u3053\u306e\u30d5\u30a3\u30fc\u304c\u8ab2\u305b\u3089\u308c\u307e\u3059\u3002 \u533b\u85ac\u54c1\u65bd\u8a2d\u306b\u8ab2\u305b\u3089\u308c\u308b\u30d5\u30a3\u30fc FDA \u306fGDUFA\u306b\u57fa\u3065\u304d\u3001API\uff08\u539f\u85ac\uff09\u65bd\u8a2d\u3001FDF\u65bd\u8a2d\u3001\u533b\u85ac\u54c1\u88fd\u9020\u53d7\u8a17\u6a5f\u95a2\uff08CMO\uff09\u306e\u30d5\u30a3\u30fc\u3092\u67fb\u5b9a\u3057\u3001\u5fb4\u53ce\u3057\u307e\u3059\u3002\u7c73\u56fd\u5916\u306e\u65bd\u8a2d\u306b\u8ab2\u305b\u3089\u308c\u308b\u30d5\u30a3\u30fc\u306f\u691c\u67fb\u306b\u304b\u304b\u308b\u8ffd\u52a0\u8cbb\u7528\u3092\u88dc\u511f\u3059\u308b\u305f\u3081\u306b\u9ad8\u304f\u306a\u3063\u3066\u3044\u307e\u3059\u3002 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2022 \u5e74\u5ea6\u306eGDUFA\u306b\u3088\u308b \u30d5\u30a3\u30fc \u30d5\u30a3\u30fc\u306e\u7a2e\u985e 2021\u5e74\u5ea6 2022\u5e74\u5ea6 \u65bd\u8a2d\u30d5\u30a3\u30fc \u7c73\u56fd\u5185 \u7c73\u56fd\u5916 \u7c73\u56fd\u5185 \u7c73\u56fd\u5916 API\u65bd\u8a2d $41,671 $56,671 $42,557 $57,557 FDF\u65bd\u8a2d $184,022 $199,022 $195,012 $210,012 Contract Manufacturing Organization (CMO) $61,341 $76,341 $65,004 $80,004 GDUFA \u306b\u3088\u308b\u30d7\u30ed\u30b0\u30e9\u30e0\u30d5\u30a3\u30fc\uff1a\u627f\u8a8d\u3055\u308c\u305fANDA\uff08\u7c21\u6613\u65b0\u85ac\u627f\u8a8d\u7533\u8acb\uff09\u306e\u6570\u306b\u57fa\u3065\u304f \u5927\u898f\u6a21 (ANDA20\u4ef6\u4ee5\u4e0a) $1,542,993 $1,536,856 \u4e2d\u898f\u6a21 (ANDA6\u301c19\u4ef6) $617,197 $614,742 \u5c0f\u898f\u6a21 (ANDA5\u4ef6\u4ee5\u4e0b) $154,299 $153,686 \u7533\u8acb\u30d5\u30a3\u30fc ANDA $196,868 $225,712 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content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA\u304c2022\u5e74\u5ea6\u306b\u5411\u3051\u305f\u533b\u7642\u6a5f\u5668\u304a\u3088\u3073\u5f8c\u767a\u54c1\u306e\u65b0\u305f\u306a\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u3092\u767a\u8868\" \/>\n<meta property=\"og:description\" content=\"FDA\u306f\u3001\u5f8c\u767a\u54c1\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u306e\u6539\u6b63\uff08GDUFA\uff09\u3068\u533b\u85ac\u54c1\u30e6\u30fc\u30b6\u30fc\u30d5\u30a3\u30fc\u306e\u6539\u6b63\uff08MDUFA\uff09\u3092\u3082\u3068\u306b\u30012022\u5e74\u5ea6\u306e\u65b0\u305f\u306a\u30d5\u30a3\u30fc\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002 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2022 \u5e74\u5ea6\u306eGDUFA\u306b\u3088\u308b \u30d5\u30a3\u30fc \u30d5\u30a3\u30fc\u306e\u7a2e\u985e 2021\u5e74\u5ea6 2022\u5e74\u5ea6 \u65bd\u8a2d\u30d5\u30a3\u30fc \u7c73\u56fd\u5185 \u7c73\u56fd\u5916 \u7c73\u56fd\u5185 \u7c73\u56fd\u5916 API\u65bd\u8a2d $41,671 $56,671 $42,557 $57,557 FDF\u65bd\u8a2d $184,022 $199,022 $195,012 $210,012 Contract Manufacturing Organization (CMO) $61,341 $76,341 $65,004 $80,004 GDUFA \u306b\u3088\u308b\u30d7\u30ed\u30b0\u30e9\u30e0\u30d5\u30a3\u30fc\uff1a\u627f\u8a8d\u3055\u308c\u305fANDA\uff08\u7c21\u6613\u65b0\u85ac\u627f\u8a8d\u7533\u8acb\uff09\u306e\u6570\u306b\u57fa\u3065\u304f \u5927\u898f\u6a21 (ANDA20\u4ef6\u4ee5\u4e0a) $1,542,993 $1,536,856 \u4e2d\u898f\u6a21 (ANDA6\u301c19\u4ef6) $617,197 $614,742 \u5c0f\u898f\u6a21 (ANDA5\u4ef6\u4ee5\u4e0b) $154,299 $153,686 \u7533\u8acb\u30d5\u30a3\u30fc ANDA $196,868 $225,712 \u30bf\u30a4\u30d7\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/jp\/fda-announces-new-medical-device-and-generic-drug-user-fees-for-fy-2022\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2021-08-05T14:13:22+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2021-08-17T19:49:48+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1650\" \/>\n\t<meta property=\"og:image:height\" content=\"500\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Mason Grandusky\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Mason Grandusky\" \/>\n<script type=\"application\/ld+json\" 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