{"id":58683,"date":"2015-09-15T20:28:44","date_gmt":"2015-09-16T00:28:44","guid":{"rendered":"https:\/\/rarediseases.org\/fda-another-tool-helping-developers-navigate-the-difficult-road-to-approval-of-drugs-for-rare-diseases\/"},"modified":"2015-09-15T20:28:44","modified_gmt":"2015-09-16T00:28:44","slug":"fda-another-tool-helping-developers-navigate-the-difficult-road-to-approval-of-drugs-for-rare-diseases","status":"publish","type":"post","link":"https:\/\/rarediseases.org\/es\/fda-another-tool-helping-developers-navigate-the-difficult-road-to-approval-of-drugs-for-rare-diseases\/","title":{"rendered":"FDA: Another tool helping developers navigate the difficult road to approval of drugs for rare diseases"},"content":{"rendered":"<p>Today, the FDA released a <a href=\"https:\/\/blogs.fda.gov\/fdavoice\/index.php\/2015\/09\/another-tool-helping-developers-navigate-the-difficult-road-to-approval-of-drugs-for-rare-diseases\/?source=govdelivery&amp;utm_medium=email&amp;utm_source=govdelivery\" target=\"_blank\" rel=\"noopener nofollow\">blog post<\/a> about a new tool for drug developers. \u00a0The FDA writes, &#8220;With the vast majority of rare diseases still without FDA-approved treatments, we have recently released a new resource for drug developers \u2014 <a href=\"https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM458485.pdf\" rel=\"nofollow noopener\" target=\"_blank\">draft guidance document<\/a> \u2014 designed to help them navigate the difficult and unique challenges of developing and bringing to market new FDA-approved drugs to treat rare diseases.&#8221;<\/p>\n<p>The FDA intends for its draft\u00a0guidance to help drug developers create more accurate and timely drug development programs by encouraging<\/p>\n<ul>\n<li>a focus on understanding a disease\u2019s \u201cnatural history,\u201d<\/li>\n<li>creation of study designs with clinically meaningful endpoints,<\/li>\n<li>development of evidence needed to establish safety and effectiveness,<\/li>\n<li>and the establishment of drug manufacturing specifications to ensure quality.<\/li>\n<\/ul>\n<p>To read the draft guidance, visit:\u00a0https:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM458485.pdf.<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Today, the FDA released a blog post about a new tool for drug developers. \u00a0The FDA writes, &#8220;With the vast majority of rare diseases still without FDA-approved treatments, we have &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/rarediseases.org\/es\/fda-another-tool-helping-developers-navigate-the-difficult-road-to-approval-of-drugs-for-rare-diseases\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA: Another tool helping developers navigate the difficult road to approval of drugs for rare diseases&#8221;<\/span><\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","_price":"","_stock":"","_tribe_ticket_header":"","_tribe_default_ticket_provider":"","_tribe_ticket_capacity":"","_ticket_start_date":"","_ticket_end_date":"","_tribe_ticket_show_description":"","_tribe_ticket_show_not_going":false,"_tribe_ticket_use_global_stock":"","_tribe_ticket_global_stock_level":"","_global_stock_mode":"","_global_stock_cap":"","_tribe_rsvp_for_event":"","_tribe_ticket_going_count":"","_tribe_ticket_not_going_count":"","_tribe_tickets_list":"[]","_tribe_ticket_has_attendee_info_fields":false,"footnotes":""},"categories":[232,210],"tags":[924,270,244,926,925,861],"class_list":["post-58683","post","type-post","status-publish","format-standard","hentry","category-advocacy","category-industry","tag-draft-guidance","tag-drug-development","tag-fda","tag-industry","tag-natural-history-studies","tag-registries"],"acf":[],"_links":{"self":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/posts\/58683","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/comments?post=58683"}],"version-history":[{"count":0,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/posts\/58683\/revisions"}],"wp:attachment":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/media?parent=58683"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/categories?post=58683"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/tags?post=58683"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}