{"id":40648,"date":"2018-08-01T14:13:00","date_gmt":"2018-08-01T18:13:00","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-publishes-fy-2019-medical-device-and-generic-drug-user-fees\/"},"modified":"2020-02-06T20:30:11","modified_gmt":"2020-02-06T20:30:11","slug":"fda-publishes-fy-2019-medical-device-and-generic-drug-user-fees","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/es\/fda-publishes-fy-2019-medical-device-and-generic-drug-user-fees\/","title":{"rendered":"FDA Publica las Cuotas de Usuario para el A\u00f1o Fiscal 2019 aplicables a Dispositivos M\u00e9dicos y Medicamentos Gen\u00e9ricos"},"content":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de los EE.UU. (FDA) recientemente public\u00f3 la programaci\u00f3n de cuotas para el A\u00f1o Fiscal (FY) 2019 para <a href=\"https:\/\/www.federalregister.gov\/documents\/2018\/07\/27\/2018-16067\/generic-drug-user-fee-rates-for-fiscal-year-2019\" target=\"_blank\" rel=\"noopener noreferrer\">Generic Drug User Fee Amendments (GDUFA)<\/a> y <a href=\"https:\/\/www.federalregister.gov\/documents\/2018\/07\/30\/2018-16178\/medical-device-user-fee-rates-for-fiscal-year-2019\" target=\"_blank\" rel=\"noopener noreferrer\">Medical Device User Fee Amendments (MDUFA)<\/a>. Las tarifas para el FY 2019 de ambas enmiendas toman efecto el 1 de Octubre de 2018. Con la intenci\u00f3n de mantener a la industria actualizada, Registrar Corp lista los pr\u00f3ximos cambios a estas tarifas a continuaci\u00f3n.<\/p>\n<p><strong>Cuotas para Instalaciones de Medicamentos<\/strong><br \/>\nGDUFA requiere cuotas de usuario para ciertos tipos de establecimientos de medicamentos. El primero de Octubre de 2018, los establecimientos de medicamentos gen\u00e9ricos son requeridos de pagar cualquier cuota de establecimiento aplicable a la FDA. Adicionalmente, GDUFA requiere cuotas por aplicaciones nuevas de Drug Master File Tipo II (DMF) y Aplicaciones Abreviadas para Nuevo Medicamento (ANDA) que deben ser pagadas a FDA.<\/p>\n<p><strong>Cambios Notables a GDUFA para el FY 2019<\/strong><\/p>\n<ul>\n<li><strong><em>Programa de Cuotas para ANDA<\/em><\/strong> \u2013 En el FY 2018, FDA introdujo un programa de cuotas para los due\u00f1os de ANDAs. Estas instalaciones pagan una cuota de usuario basada en el n\u00famero de ANDAs aprobadas y mantenidas al 1 de Octubre del a\u00f1o otorgado. El FY 2019, el programa de cuotas ANDA reflejar\u00e1 un incremento del 17% aproximadamente comparado con el a\u00f1o previo.<\/li>\n<li id=\"gdufafees\"><strong><em>Cuotas por Presentaciones de DMF Tipo II<\/em><\/strong> \u2013 En el FY 2018, la cuota por una \u00fanica presentaci\u00f3n de DMF Tipo II a la FDA era de $47,829 USD. Para el FY 2019 veremos un incremento de aproximadamente del 15% dando como resultado una cuota de $55,013 USD.<\/li>\n<\/ul>\n<p>Puede visualizar una comparaci\u00f3n de las cuotas GDUFA para FY 2018 y el FY 2019 a continuaci\u00f3n:<\/p>\n<p><strong>Cuotas GDUFA FY 2019<\/strong><\/p>\n<table class=\"feeTable\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" width=\"313\"><strong>Tipo de Cuota<\/strong><\/td>\n<td class=\"dark-bg\" colspan=\"2\" width=\"168\"><strong>2018<\/strong><\/td>\n<td class=\"dark-bg\" colspan=\"2\" width=\"157\"><strong>2019<\/strong><\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" width=\"313\"><strong>Cuotas de Instalaci\u00f3n<\/strong><\/td>\n<td class=\"dark-bg\" width=\"90\"><strong>EEUU<\/strong><\/td>\n<td class=\"dark-bg\" width=\"78\"><strong>Extranjera<\/strong><\/td>\n<td class=\"dark-bg\" width=\"78\"><strong>EEUU<\/strong><\/td>\n<td class=\"dark-bg\" width=\"79\"><strong>Extranjera<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Active Pharmaceutical Ingredient (API)<\/td>\n<td width=\"90\">$45,367<\/td>\n<td width=\"78\">$60,367<\/td>\n<td width=\"78\">$44,226<\/td>\n<td width=\"79\">$59,226<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Finished Dosage Form (FDF)<\/td>\n<td width=\"90\">$211,087<\/td>\n<td width=\"78\">$226,087<\/td>\n<td width=\"78\">$211,305<\/td>\n<td width=\"79\">$226,305<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Contract Manufacturing Organization (CMO)<\/td>\n<td width=\"90\">$70,362<\/td>\n<td width=\"78\">$85,362<\/td>\n<td width=\"78\">$70,435<\/td>\n<td width=\"79\">$85,435<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" colspan=\"5\" width=\"638\"><strong>Programa de Cuotas ANDA \u2013 Basado en el n\u00famero de ANDAs mantenidos<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Large (20 or more ANDAs)<\/td>\n<td colspan=\"2\" width=\"168\">$1,590,792<\/td>\n<td colspan=\"2\" width=\"157\">$1,862,167<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Medium (6 \u2013 19 ANDAs)<\/td>\n<td colspan=\"2\" width=\"168\">$636,317<\/td>\n<td colspan=\"2\" width=\"157\">$744,867<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Small (5 or fewer ANDAs)<\/td>\n<td colspan=\"2\" width=\"168\">$159,079<\/td>\n<td colspan=\"2\" width=\"157\">$186,217<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" colspan=\"5\" width=\"638\"><strong>Cuotas de Aplicaci\u00f3n<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"313\">ANDA<\/td>\n<td colspan=\"2\" width=\"168\">$171,823<\/td>\n<td colspan=\"2\" width=\"157\">$178,799<\/td>\n<\/tr>\n<tr>\n<td width=\"313\">Type II DMF<\/td>\n<td colspan=\"2\" width=\"168\">$47,829<\/td>\n<td colspan=\"2\" width=\"157\">$55,013<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em><b>*Montos en D\u00f3lares Americanos (USD)<\/b><\/em><\/p>\n<hr \/>\n<p><strong>Cuotas para Establecimientos de Medicamentos<\/strong><br \/>\nMDUFA requiere que todos los establecimientos registrados con FDA paguen una cuota de usuario durante la renovaci\u00f3n anual de su registro. La cuota de registro de establecimiento para el FY 2019 es de $4,884 USD siendo aplicable a todos los establecimientos. <a href=\"https:\/\/www.federalregister.gov\/documents\/2018\/07\/30\/2018-16178\/medical-device-user-fee-rates-for-fiscal-year-2019#h-20\">De acuerdo a la publicaci\u00f3n de las cuotas MDUFA<\/a>, FDA no reconoce a un establecimiento como legalmente registrado hasta que esta cuota sea pagada.<\/p>\n<p>Adicionalmente, MDUFA requiere el pago de cuotas para ciertas presentaciones de aplicaciones para dispositivos m\u00e9dicos ante la FDA. Las peque\u00f1as empresa, definidas por MDUFA por tener ventas netas o recibos no mayores a m\u00e1s de $100 millones de USD durante el a\u00f1o fiscal m\u00e1s reciente, pudieran calificar para descuentos en las cuotas que les apliquen. Todas las cuotas de aplicaciones para dispositivos m\u00e9dicos reflejan un incremento del 3-4% aproximadamente comparado con el a\u00f1o previo.<\/p>\n<p>Puede visualizar una comparaci\u00f3n de las cuotas MDUFA para FY 2018 y el FY 2019 a continuaci\u00f3n:<\/p>\n<p><strong>Cuotas MDUFA FY 2019<\/strong><\/p>\n<table class=\"feeTable\" border=\"1\" width=\"100%\">\n<tbody>\n<tr>\n<td class=\"dark-bg\" width=\"229\"><strong>Tipo de Cuota<\/strong><\/td>\n<td class=\"dark-bg\" colspan=\"2\" width=\"196\"><strong>2018<\/strong><\/td>\n<td class=\"dark-bg\" colspan=\"2\" width=\"213\"><strong>2019<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">Annual Establishment Registration<\/td>\n<td colspan=\"2\" width=\"196\">$4,624<\/td>\n<td colspan=\"2\" width=\"213\">$4,884<\/td>\n<\/tr>\n<tr>\n<td class=\"dark-bg\" width=\"229\"><strong>Cuotas de Aplicaci\u00f3n<\/strong><\/td>\n<td class=\"dark-bg\" width=\"90\"><strong>Est\u00e1ndar<\/strong><\/td>\n<td class=\"dark-bg\" width=\"106\"><strong>Empresa Peque\u00f1a<\/strong><\/td>\n<td class=\"dark-bg\" width=\"106\"><strong>Est\u00e1ndar<\/strong><\/td>\n<td class=\"dark-bg\" width=\"106\"><strong>Empresa Peque\u00f1a<\/strong><\/td>\n<\/tr>\n<tr>\n<td width=\"229\">510(k)<\/td>\n<td width=\"90\">$10,566<\/td>\n<td width=\"106\">$2,642<\/td>\n<td width=\"106\">$10,953<\/td>\n<td width=\"106\">$2,738<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">513(g)<\/td>\n<td width=\"90\">$4,195<\/td>\n<td width=\"106\">$2,098<\/td>\n<td width=\"106\">$4,349<\/td>\n<td width=\"106\">$2,175<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">De Novo Classification<\/td>\n<td width=\"90\">$93,229<\/td>\n<td width=\"106\">$23,307<\/td>\n<td width=\"106\">$96,644<\/td>\n<td width=\"106\">$24,161<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">PMA, PDP, PMR, BLA<\/td>\n<td width=\"90\">$310,764<\/td>\n<td width=\"106\">$77,691<\/td>\n<td width=\"106\">$322,147<\/td>\n<td width=\"106\">$80,537<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">panel-track supplement<\/td>\n<td width=\"90\">$233,073<\/td>\n<td width=\"106\">$58,268<\/td>\n<td width=\"106\">$241,610<\/td>\n<td width=\"106\">$60,403<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">180-day supplement<\/td>\n<td width=\"90\">$46,615<\/td>\n<td width=\"106\">$11,654<\/td>\n<td width=\"106\">$48,322<\/td>\n<td width=\"106\">$12,081<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">real-time supplement<\/td>\n<td width=\"90\">$21,753<\/td>\n<td width=\"106\">$5,438<\/td>\n<td width=\"106\">$22,550<\/td>\n<td width=\"106\">$5,638<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">BLA efficacy supplement<\/td>\n<td width=\"90\">$310,764<\/td>\n<td width=\"106\">$77,691<\/td>\n<td width=\"106\">$322,147<\/td>\n<td width=\"106\">$80,537<\/td>\n<\/tr>\n<tr>\n<td width=\"229\">PMA annual report<\/td>\n<td width=\"90\">$10,877<\/td>\n<td width=\"106\">$2,719<\/td>\n<td width=\"106\">$11,275<\/td>\n<td width=\"106\">$2,819<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><em><b>*Montos en D\u00f3lares Americanos (USD)<\/b><\/em><\/p>\n<p>\u00bfNo est\u00e1 seguro de cuales cuotas pudieran aplicarle? Los Especialistas Regulatorio de Registrar Corp pueden ayudarle a determinar sus cuotas aplicables y facilitarle el proceso de pago a FDA. Ll\u00e1menos al +1-757-224-0177 o contacte con un Asesor Regulatorio las 24 horas del d\u00eda en nuestro chat: <a href=\"https:\/\/regstaging.wpengine.com\/livehelp\">regstaging.wpengine.com\/livehelp<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La Administraci\u00f3n de Alimentos y Medicamentos de los EE.UU. (FDA) recientemente public\u00f3 la programaci\u00f3n de cuotas para el A\u00f1o Fiscal (FY) 2019 para Generic Drug User Fee Amendments (GDUFA) y Medical Device User Fee Amendments (MDUFA). Las tarifas para el FY 2019 de ambas enmiendas toman efecto el 1 de Octubre de 2018. Con la<\/p>\n","protected":false},"author":2,"featured_media":40016,"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":[61,60],"tags":[],"class_list":["post-40648","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medical-devices-es","category-drugs-es","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 Publica las Cuotas de Usuario para el A\u00f1o Fiscal 2019 aplicables a Dispositivos M\u00e9dicos y Medicamentos Gen\u00e9ricos - 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=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA Publica las Cuotas de Usuario para el A\u00f1o Fiscal 2019 aplicables a Dispositivos M\u00e9dicos y Medicamentos Gen\u00e9ricos\" \/>\n<meta property=\"og:description\" content=\"La Administraci\u00f3n de Alimentos y Medicamentos de los EE.UU. 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