{"id":40863,"date":"2019-08-20T10:05:28","date_gmt":"2019-08-20T14:05:28","guid":{"rendered":"https:\/\/regstaging.wpengine.com\/fda-to-remove-thousands-of-drug-listings-on-september-12-2019-make-sure-yours-is-not-one-of-them\/"},"modified":"2020-02-10T16:22:08","modified_gmt":"2020-02-10T16:22:08","slug":"fda-to-remove-thousands-of-drug-listings-on-september-12-2019-make-sure-yours-is-not-one-of-them","status":"publish","type":"post","link":"https:\/\/legacy.registrarcorp.com\/it\/fda-to-remove-thousands-of-drug-listings-on-september-12-2019-make-sure-yours-is-not-one-of-them\/","title":{"rendered":"La FDA rimuover\u00e1 migliaia di Listing di farmaci il 12 settembre 2019; assicuratevi che i vostri non siano tra questi"},"content":{"rendered":"<p>La U.S. Food and Drug Administration (FDA) richiede a tutti i produttori farmaceutici che commercializzano medicinali negli Stati Uniti di registrare i propri stabilimenti e di sottomettere ciascun farmaco (Listing) prodotto in quegli stabilimenti. Il 12 settembre 2019, la <a href=\"https:\/\/www.fda.gov\/news-events\/fda-brief\/fda-brief-fda-takes-new-steps-improve-drug-supply-chain-integrity-and-patient-safety-announcing-its?utm_campaign=081319_FIB_The%20FDA%20is%20taking%20new%20steps%20to%20begin%20inactivating%20outdated%20drug%20listing%20records&amp;utm_medium=email&amp;utm_source=Eloqua\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">FDA rimuover\u00e1 dal suo database qualsiasi Listing contenente informazioni non aggiornate o incomplete<\/a>, proibendo di fatto la vendita e la distribuzione del farmaco negli Stati Uniti.<\/p>\r\n<!-- \/wp:post-content -->\r\n\r\n<!-- wp:paragraph -->\r\n<p><strong>Rinnovo della registratione e dei Listing<\/strong><\/p>\r\n<!-- \/wp:paragraph -->\r\n\r\n<!-- wp:paragraph -->\r\n<p>La FDA richiede che gli aggiornamenti apportati ai farmaci presenti nei Listing siano presentati due volte all\u2019anno, a giugno e a dicembre. A partire dal 2017, se nessun cambiamento o aggiornamento \u00e9 richiesto, i produttori farmceutici devono inviare <a href=\"https:\/\/regstaging.wpengine.com\/it\/fda-introduces-annual-certification-requirement-for-unchanged-drug-product-listings\/?lead_source=blog\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">\u00a0una \u2018blanket no change certification\u2019<\/a> per questi Listing. Il mancato aggiornamento o certificazione di un Listing di un farmaco durante il periodo di rinnovo pu\u00f3 portare la FDA a considerare tale Listing non aggiornato o incompleto, causando la disattivazione del Listing stesso. Commercializzare o importare farmaci con Listing non attivi negli Stati Uniti \u00e9 considerato un atto proibito.<\/p>\r\n<!-- \/wp:paragraph -->\r\n\r\n<!-- wp:paragraph -->\r\n<p>Secondo la FDA, nel suo database sono presenti decine di migliaia di Listing farmaceutici che non sono aggiornati o sono incompleti. La FDA considera disattivato il Listing di un farmaco finch\u00e9 questo non viene aggiornato o viene presentata la certificazione adeguata.<\/p>\r\n<!-- \/wp:paragraph -->\r\n\r\n<!-- wp:paragraph -->\r\n<p>Inoltre, la FDA richiede che il rinnovo delle registrazioni degli stabilimenti farmaceutici avvenga annualmente tra il 1\u00b0 ottobre e il 31 dicembre. Il mancato rinnovo della registrazione durante questo periodo pu\u00f3 far s\u00ed che la FDA consideri scaduta la registrazione, impedendo quindi all\u2019azienda di commercializzare i propri prodotti negli Stati Uniti. I Listing di farmaci che sono associati a stabilimenti che non hanno rinnovato la propria registrazione saranno a loro volta rimossi dal database della FDA. Registrar Corp assiste le aziende ad adeguarsi alla normativa della FDA. Registrar Corp pu\u00f3 <a href=\"https:\/\/regstaging.wpengine.com\/it\/fda-drugs\/registration\/?lead_source=blog&amp;no_redirect\">aggiornare in modo adeguato i vostri Listing<\/a> per evitare che siano rimossi dal database della FDA. Possiamo anche <a href=\"https:\/\/regstaging.wpengine.com\/it\/fda-drugs\/verify\/?lead_source=blog\">verificare che la registrazione del vostro stabilimento e i Listing<\/a> siano presenti correttamente nel database FDA. Per maggiori informazioni, chiamateci al +1-757-224-0177 o contattate uno dei nostri specialisti 24\/7 tramite il servizio chat <a href=\"https:\/\/regstaging.wpengine.com\/livehelp\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\" (opens in a new tab)\">regstaging.wpengine.com\/livehelp<\/a><\/p>\r\n<!-- wp:paragraph \/-->","protected":false},"excerpt":{"rendered":"<p>La U.S. Food and Drug Administration (FDA) richiede a tutti i produttori farmaceutici che commercializzano medicinali negli Stati Uniti di registrare i propri stabilimenti e di sottomettere ciascun farmaco (Listing) prodotto in quegli stabilimenti. Il 12 settembre 2019, la FDA rimuover\u00e1 dal suo database qualsiasi Listing contenente informazioni non aggiornate o incomplete, proibendo di fatto<\/p>\n","protected":false},"author":2,"featured_media":39858,"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":[78],"tags":[],"class_list":{"0":"post-40863","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-drugs-it","8":"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>La FDA rimuover\u00e1 migliaia di Listing di farmaci il 12 settembre 2019; assicuratevi che i vostri non siano tra questi - 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=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La FDA rimuover\u00e1 migliaia di Listing di farmaci il 12 settembre 2019; assicuratevi che i vostri non siano tra questi\" \/>\n<meta property=\"og:description\" content=\"La U.S. Food and Drug Administration (FDA) richiede a tutti i produttori farmaceutici che commercializzano medicinali negli Stati Uniti di registrare i propri stabilimenti e di sottomettere ciascun farmaco (Listing) prodotto in quegli stabilimenti. 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