{"id":40820,"date":"2016-08-01T15:16:36","date_gmt":"2016-08-01T15:16:36","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/"},"modified":"2020-02-07T21:26:57","modified_gmt":"2020-02-07T21:26:57","slug":"fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/","title":{"rendered":"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6"},"content":{"rendered":"<p>\u65e5\u524d\uff0cFDA\u516c\u5e03\u4e86\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f2017\u8d22\u653f\u5e74\u5ea6\uff082016\u5e7410\u67081\u65e5\u81f32017\u5e749\u670830\u65e5\uff09\u5e74\u5ea6\u6536\u8d39\u8ba1\u5212\u3002<\/p>\n<p><strong>\u533b\u7597\u5668\u68b02017<\/strong><strong>\u8d22\u5e74\u6536\u8d39\u8ba1\u5212<\/strong><\/p>\n<ul>\n<li>FDA\u5b98\u65b9\u8d39\u7528\uff1a$3,382\uff08\u5c0f\u578b\u4f01\u4e1a\u4e0d\u53ef\u8c41\u514d\uff09<\/li>\n<li>\u4e0a\u5e02\u524d\u7533\u8bf7(PMA, BLA, PDP): $234,495\/ \u5c0f\u578b\u4f01\u4e1a\u4e3a$58,624<\/li>\n<li>\u4e0a\u5e02\u524d\u901a\u77e5\uff08510(k)\uff09\uff1a$4,690 \/\u5c0f\u578b\u4f01\u4e1a\u4e3a$ 2,345<\/li>\n<li>513(g) \u5206\u7c7b\u4fe1\u606f\uff1a$3,166 \/\u5c0f\u578b\u4f01\u4e1a\u4e3a$1,583<\/li>\n<li>PMA\u5e74\u5ea6\u62a5\u544a\uff1a$8,207\u5c0f\u578b\u4f01\u4e1a\u4e3a$2,052<\/li>\n<\/ul>\n<p>2017\u8d22\u5e74\u7684\u533b\u7597\u5668\u68b0\u8d39\u7528\u8f832016\u8d22\u5e74\u6709\u6240\u4e0b\u964d\u3002<\/p>\n<p>Registrar Corp\u53ef\u4e3a\u60a8\u5411FDA\u5b8c\u6210\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c\u548c\u5ba1\u6838510(k)\u662f\u5426\u7b26\u5408\u9012\u4ea4\u8981\u6c42\u3002<\/p>\n<p><strong>Generic Drug User Fees for FY 2017<\/strong><\/p>\n<p><strong>\u4eff\u5236\u836f2017<\/strong><strong>\u8d22\u5e74\u6536\u8d39\u8ba1\u5212<\/strong><\/p>\n<p>\u7533\u8bf7\u8d39\u7528<\/p>\n<ul>\n<li>\u7b80\u660e\u65b0\u836f\u7533\u8bf7(ANDA)\uff1a$70,480<\/li>\n<li>ANDA\u5df2\u83b7\u6279\u7533\u8bf7\u7684\u8865\u5145\u7533\u8bf7(PAS)\uff1a$35,240<\/li>\n<li>\u836f\u54c1\u4e3b\u6863\u6848(DMF)\uff1a$51,140<\/li>\n<\/ul>\n<p>\u573a\u5730\u8d39\u7528<\/p>\n<ul>\n<li>\u6d3b\u6027\u836f\u7269\u6210\u5206(API) \u2014\u7f8e\u56fd\u5883\u5185: $44,234<\/li>\n<li>API\u2014\u7f8e\u56fd\u5883\u5916: $59,234<\/li>\n<li>\u5236\u5242\u836f\u7269(FDF) \u2014\u7f8e\u56fd\u5883\u5185: $258,646<\/li>\n<li>FDF\u2014\u7f8e\u56fd\u5883\u5916: $273,646<\/li>\n<\/ul>\n<p>2017\u8d22\u5e74\u7684ANDA\u548cPAS\u7533\u8bf7\u8d39\u7528\u8f832016\u8d22\u5e74\u6709\u6240\u4e0b\u964d\uff0c\u800c2017\u8d22\u5e74\u7684DMF\u7533\u8bf7\u8d39\u7528\u3001API\u573a\u5730\u8d39\u7528\u548cFDF\u573a\u5730\u8d39\u7528\u8f832016\u8d22\u5e74\u5219\u6709\u6240\u4e0a\u8c03\u3002<\/p>\n<p>Registrar Corp\u53ef\u4e3a\u60a8\u5411FDA\u5b8c\u6210\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u548c\u9012\u4ea4DMF\u3002<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u65e5\u524d\uff0cFDA\u516c\u5e03\u4e86\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f2017\u8d22\u653f\u5e74\u5ea6\uff082016\u5e7410\u67081\u65e5\u81f32017\u5e749\u670830\u65e5\uff09\u5e74\u5ea6\u6536\u8d39\u8ba1\u5212\u3002 \u533b\u7597\u5668\u68b02017\u8d22\u5e74\u6536\u8d39\u8ba1\u5212 FDA\u5b98\u65b9\u8d39\u7528\uff1a$3,382\uff08\u5c0f\u578b\u4f01\u4e1a\u4e0d\u53ef\u8c41\u514d\uff09 \u4e0a\u5e02\u524d\u7533\u8bf7(PMA, BLA, PDP): $234,495\/ \u5c0f\u578b\u4f01\u4e1a\u4e3a$58,624 \u4e0a\u5e02\u524d\u901a\u77e5\uff08510(k)\uff09\uff1a$4,690 \/\u5c0f\u578b\u4f01\u4e1a\u4e3a$ 2,345 513(g) \u5206\u7c7b\u4fe1\u606f\uff1a$3,166 \/\u5c0f\u578b\u4f01\u4e1a\u4e3a$1,583 PMA\u5e74\u5ea6\u62a5\u544a\uff1a$8,207\u5c0f\u578b\u4f01\u4e1a\u4e3a$2,052 2017\u8d22\u5e74\u7684\u533b\u7597\u5668\u68b0\u8d39\u7528\u8f832016\u8d22\u5e74\u6709\u6240\u4e0b\u964d\u3002 Registrar Corp\u53ef\u4e3a\u60a8\u5411FDA\u5b8c\u6210\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c\u548c\u5ba1\u6838510(k)\u662f\u5426\u7b26\u5408\u9012\u4ea4\u8981\u6c42\u3002 Generic Drug User Fees for FY 2017 \u4eff\u5236\u836f2017\u8d22\u5e74\u6536\u8d39\u8ba1\u5212 \u7533\u8bf7\u8d39\u7528 \u7b80\u660e\u65b0\u836f\u7533\u8bf7(ANDA)\uff1a$70,480 ANDA\u5df2\u83b7\u6279\u7533\u8bf7\u7684\u8865\u5145\u7533\u8bf7(PAS)\uff1a$35,240 \u836f\u54c1\u4e3b\u6863\u6848(DMF)\uff1a$51,140 \u573a\u5730\u8d39\u7528 \u6d3b\u6027\u836f\u7269\u6210\u5206(API) \u2014\u7f8e\u56fd\u5883\u5185: $44,234 API\u2014\u7f8e\u56fd\u5883\u5916: $59,234 \u5236\u5242\u836f\u7269(FDF) \u2014\u7f8e\u56fd\u5883\u5185: $258,646 FDF\u2014\u7f8e\u56fd\u5883\u5916: $273,646 2017\u8d22\u5e74\u7684ANDA\u548cPAS\u7533\u8bf7\u8d39\u7528\u8f832016\u8d22\u5e74\u6709\u6240\u4e0b\u964d\uff0c\u800c2017\u8d22\u5e74\u7684DMF\u7533\u8bf7\u8d39\u7528\u3001API\u573a\u5730\u8d39\u7528\u548cFDF\u573a\u5730\u8d39\u7528\u8f832016\u8d22\u5e74\u5219\u6709\u6240\u4e0a\u8c03\u3002 Registrar Corp\u53ef\u4e3a\u60a8\u5411FDA\u5b8c\u6210\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u548c\u9012\u4ea4DMF\u3002<\/p>\n","protected":false},"author":30,"featured_media":39533,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","om_disable_all_campaigns":false,"inline_featured_image":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[69,68],"tags":[],"class_list":["post-40820","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medical-devices-zh","category-drugs-zh","entry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.9 (Yoast SEO v25.5) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6 - Registrar<\/title>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"zh_CN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6\" \/>\n<meta property=\"og:description\" content=\"\u65e5\u524d\uff0cFDA\u516c\u5e03\u4e86\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f2017\u8d22\u653f\u5e74\u5ea6\uff082016\u5e7410\u67081\u65e5\u81f32017\u5e749\u670830\u65e5\uff09\u5e74\u5ea6\u6536\u8d39\u8ba1\u5212\u3002 \u533b\u7597\u5668\u68b02017\u8d22\u5e74\u6536\u8d39\u8ba1\u5212 FDA\u5b98\u65b9\u8d39\u7528\uff1a$3,382\uff08\u5c0f\u578b\u4f01\u4e1a\u4e0d\u53ef\u8c41\u514d\uff09 \u4e0a\u5e02\u524d\u7533\u8bf7(PMA, BLA, PDP): $234,495\/ \u5c0f\u578b\u4f01\u4e1a\u4e3a$58,624 \u4e0a\u5e02\u524d\u901a\u77e5\uff08510(k)\uff09\uff1a$4,690 \/\u5c0f\u578b\u4f01\u4e1a\u4e3a$ 2,345 513(g) \u5206\u7c7b\u4fe1\u606f\uff1a$3,166 \/\u5c0f\u578b\u4f01\u4e1a\u4e3a$1,583 PMA\u5e74\u5ea6\u62a5\u544a\uff1a$8,207\u5c0f\u578b\u4f01\u4e1a\u4e3a$2,052 2017\u8d22\u5e74\u7684\u533b\u7597\u5668\u68b0\u8d39\u7528\u8f832016\u8d22\u5e74\u6709\u6240\u4e0b\u964d\u3002 Registrar Corp\u53ef\u4e3a\u60a8\u5411FDA\u5b8c\u6210\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c\u548c\u5ba1\u6838510(k)\u662f\u5426\u7b26\u5408\u9012\u4ea4\u8981\u6c42\u3002 Generic Drug User Fees for FY 2017 \u4eff\u5236\u836f2017\u8d22\u5e74\u6536\u8d39\u8ba1\u5212 \u7533\u8bf7\u8d39\u7528 \u7b80\u660e\u65b0\u836f\u7533\u8bf7(ANDA)\uff1a$70,480 ANDA\u5df2\u83b7\u6279\u7533\u8bf7\u7684\u8865\u5145\u7533\u8bf7(PAS)\uff1a$35,240 \u836f\u54c1\u4e3b\u6863\u6848(DMF)\uff1a$51,140 \u573a\u5730\u8d39\u7528 \u6d3b\u6027\u836f\u7269\u6210\u5206(API) \u2014\u7f8e\u56fd\u5883\u5185: $44,234 API\u2014\u7f8e\u56fd\u5883\u5916: $59,234 \u5236\u5242\u836f\u7269(FDF) \u2014\u7f8e\u56fd\u5883\u5185: $258,646 FDF\u2014\u7f8e\u56fd\u5883\u5916: $273,646 2017\u8d22\u5e74\u7684ANDA\u548cPAS\u7533\u8bf7\u8d39\u7528\u8f832016\u8d22\u5e74\u6709\u6240\u4e0b\u964d\uff0c\u800c2017\u8d22\u5e74\u7684DMF\u7533\u8bf7\u8d39\u7528\u3001API\u573a\u5730\u8d39\u7528\u548cFDF\u573a\u5730\u8d39\u7528\u8f832016\u8d22\u5e74\u5219\u6709\u6240\u4e0a\u8c03\u3002 Registrar Corp\u53ef\u4e3a\u60a8\u5411FDA\u5b8c\u6210\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u548c\u9012\u4ea4DMF\u3002\" \/>\n<meta property=\"og:url\" content=\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\" \/>\n<meta property=\"og:site_name\" content=\"Registrar\" \/>\n<meta property=\"article:published_time\" content=\"2016-08-01T15:16:36+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2020-02-07T21:26:57+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\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\"},\"author\":{\"name\":\"Mason Grandusky\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2\"},\"headline\":\"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6\",\"datePublished\":\"2016-08-01T15:16:36+00:00\",\"dateModified\":\"2020-02-07T21:26:57+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\"},\"wordCount\":36,\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#organization\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\",\"articleSection\":[\"\u533b\u7597\u5668\u68b0\",\"\u836f\u54c1\"],\"inLanguage\":\"zh\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\",\"name\":\"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6 - Registrar\",\"isPartOf\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\",\"datePublished\":\"2016-08-01T15:16:36+00:00\",\"dateModified\":\"2020-02-07T21:26:57+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#breadcrumb\"},\"inLanguage\":\"zh\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"zh\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage\",\"url\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\",\"contentUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg\",\"width\":1650,\"height\":500},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/legacy.registrarcorp.com\/zh\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#website\",\"url\":\"https:\/\/legacy.registrarcorp.com\/zh\/\",\"name\":\"Registrar\",\"description\":\"Assistance with U.S. FDA Regulations\",\"publisher\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/legacy.registrarcorp.com\/zh\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"zh\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#organization\",\"name\":\"Registrar Corp\",\"url\":\"https:\/\/legacy.registrarcorp.com\/zh\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/12\/regcorp_logo.png\",\"contentUrl\":\"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/12\/regcorp_logo.png\",\"width\":1326,\"height\":330,\"caption\":\"Registrar Corp\"},\"image\":{\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/logo\/image\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2\",\"name\":\"Mason Grandusky\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"zh\",\"@id\":\"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/image\/\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/20ae894ac7fdae57b794f1b1792f9c9f1920bc809d0aab245d70e0aa7c997266?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/20ae894ac7fdae57b794f1b1792f9c9f1920bc809d0aab245d70e0aa7c997266?s=96&d=mm&r=g\",\"caption\":\"Mason Grandusky\"},\"url\":\"https:\/\/legacy.registrarcorp.com\/zh\/author\/mgrandusky\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6 - Registrar","robots":{"index":"noindex","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"og_locale":"zh_CN","og_type":"article","og_title":"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6","og_description":"\u65e5\u524d\uff0cFDA\u516c\u5e03\u4e86\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f2017\u8d22\u653f\u5e74\u5ea6\uff082016\u5e7410\u67081\u65e5\u81f32017\u5e749\u670830\u65e5\uff09\u5e74\u5ea6\u6536\u8d39\u8ba1\u5212\u3002 \u533b\u7597\u5668\u68b02017\u8d22\u5e74\u6536\u8d39\u8ba1\u5212 FDA\u5b98\u65b9\u8d39\u7528\uff1a$3,382\uff08\u5c0f\u578b\u4f01\u4e1a\u4e0d\u53ef\u8c41\u514d\uff09 \u4e0a\u5e02\u524d\u7533\u8bf7(PMA, BLA, PDP): $234,495\/ \u5c0f\u578b\u4f01\u4e1a\u4e3a$58,624 \u4e0a\u5e02\u524d\u901a\u77e5\uff08510(k)\uff09\uff1a$4,690 \/\u5c0f\u578b\u4f01\u4e1a\u4e3a$ 2,345 513(g) \u5206\u7c7b\u4fe1\u606f\uff1a$3,166 \/\u5c0f\u578b\u4f01\u4e1a\u4e3a$1,583 PMA\u5e74\u5ea6\u62a5\u544a\uff1a$8,207\u5c0f\u578b\u4f01\u4e1a\u4e3a$2,052 2017\u8d22\u5e74\u7684\u533b\u7597\u5668\u68b0\u8d39\u7528\u8f832016\u8d22\u5e74\u6709\u6240\u4e0b\u964d\u3002 Registrar Corp\u53ef\u4e3a\u60a8\u5411FDA\u5b8c\u6210\u533b\u7597\u5668\u68b0\u4f01\u4e1a\u6ce8\u518c\u548c\u5ba1\u6838510(k)\u662f\u5426\u7b26\u5408\u9012\u4ea4\u8981\u6c42\u3002 Generic Drug User Fees for FY 2017 \u4eff\u5236\u836f2017\u8d22\u5e74\u6536\u8d39\u8ba1\u5212 \u7533\u8bf7\u8d39\u7528 \u7b80\u660e\u65b0\u836f\u7533\u8bf7(ANDA)\uff1a$70,480 ANDA\u5df2\u83b7\u6279\u7533\u8bf7\u7684\u8865\u5145\u7533\u8bf7(PAS)\uff1a$35,240 \u836f\u54c1\u4e3b\u6863\u6848(DMF)\uff1a$51,140 \u573a\u5730\u8d39\u7528 \u6d3b\u6027\u836f\u7269\u6210\u5206(API) \u2014\u7f8e\u56fd\u5883\u5185: $44,234 API\u2014\u7f8e\u56fd\u5883\u5916: $59,234 \u5236\u5242\u836f\u7269(FDF) \u2014\u7f8e\u56fd\u5883\u5185: $258,646 FDF\u2014\u7f8e\u56fd\u5883\u5916: $273,646 2017\u8d22\u5e74\u7684ANDA\u548cPAS\u7533\u8bf7\u8d39\u7528\u8f832016\u8d22\u5e74\u6709\u6240\u4e0b\u964d\uff0c\u800c2017\u8d22\u5e74\u7684DMF\u7533\u8bf7\u8d39\u7528\u3001API\u573a\u5730\u8d39\u7528\u548cFDF\u573a\u5730\u8d39\u7528\u8f832016\u8d22\u5e74\u5219\u6709\u6240\u4e0a\u8c03\u3002 Registrar Corp\u53ef\u4e3a\u60a8\u5411FDA\u5b8c\u6210\u836f\u54c1\u4f01\u4e1a\u6ce8\u518c\u548c\u9012\u4ea4DMF\u3002","og_url":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/","og_site_name":"Registrar","article_published_time":"2016-08-01T15:16:36+00:00","article_modified_time":"2020-02-07T21:26:57+00:00","og_image":[{"width":1650,"height":500,"url":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg","type":"image\/jpeg"}],"author":"Mason Grandusky","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Mason Grandusky"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#article","isPartOf":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/"},"author":{"name":"Mason Grandusky","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2"},"headline":"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6","datePublished":"2016-08-01T15:16:36+00:00","dateModified":"2020-02-07T21:26:57+00:00","mainEntityOfPage":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/"},"wordCount":36,"publisher":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/#organization"},"image":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage"},"thumbnailUrl":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg","articleSection":["\u533b\u7597\u5668\u68b0","\u836f\u54c1"],"inLanguage":"zh"},{"@type":"WebPage","@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/","url":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/","name":"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6 - Registrar","isPartOf":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/#website"},"primaryImageOfPage":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage"},"image":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage"},"thumbnailUrl":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg","datePublished":"2016-08-01T15:16:36+00:00","dateModified":"2020-02-07T21:26:57+00:00","breadcrumb":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#breadcrumb"},"inLanguage":"zh","potentialAction":[{"@type":"ReadAction","target":["https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/"]}]},{"@type":"ImageObject","inLanguage":"zh","@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#primaryimage","url":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg","contentUrl":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/08\/press_release.jpg","width":1650,"height":500},{"@type":"BreadcrumbList","@id":"https:\/\/legacy.registrarcorp.com\/zh\/fda-publishes-fy-2017-user-fees-for-devices-and-generic-drugs\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/legacy.registrarcorp.com\/zh\/"},{"@type":"ListItem","position":2,"name":"FDA\u516c\u5e032017\u8d22\u653f\u5e74\u5ea6\u533b\u7597\u5668\u68b0\u548c\u4eff\u5236\u836f\u6536\u8d39\u6807\u51c6"}]},{"@type":"WebSite","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#website","url":"https:\/\/legacy.registrarcorp.com\/zh\/","name":"Registrar","description":"Assistance with U.S. FDA Regulations","publisher":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/legacy.registrarcorp.com\/zh\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"zh"},{"@type":"Organization","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#organization","name":"Registrar Corp","url":"https:\/\/legacy.registrarcorp.com\/zh\/","logo":{"@type":"ImageObject","inLanguage":"zh","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/logo\/image\/","url":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/12\/regcorp_logo.png","contentUrl":"https:\/\/legacy.registrarcorp.com\/wp-content\/uploads\/2019\/12\/regcorp_logo.png","width":1326,"height":330,"caption":"Registrar Corp"},"image":{"@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/5460f453ed04f326b4ef5280009675f2","name":"Mason Grandusky","image":{"@type":"ImageObject","inLanguage":"zh","@id":"https:\/\/legacy.registrarcorp.com\/zh\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/20ae894ac7fdae57b794f1b1792f9c9f1920bc809d0aab245d70e0aa7c997266?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/20ae894ac7fdae57b794f1b1792f9c9f1920bc809d0aab245d70e0aa7c997266?s=96&d=mm&r=g","caption":"Mason Grandusky"},"url":"https:\/\/legacy.registrarcorp.com\/zh\/author\/mgrandusky\/"}]}},"_links":{"self":[{"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/posts\/40820","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/users\/30"}],"replies":[{"embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/comments?post=40820"}],"version-history":[{"count":0,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/posts\/40820\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/media\/39533"}],"wp:attachment":[{"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/media?parent=40820"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/categories?post=40820"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/legacy.registrarcorp.com\/zh\/wp-json\/wp\/v2\/tags?post=40820"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}