{"id":58635,"date":"2015-09-17T22:34:56","date_gmt":"2015-09-18T02:34:56","guid":{"rendered":"https:\/\/rarediseases.org\/nord-issues-statement-on-fda-rejection-of-citizen-petition\/"},"modified":"2015-09-17T22:34:56","modified_gmt":"2015-09-18T02:34:56","slug":"nord-issues-statement-on-fda-rejection-of-citizen-petition","status":"publish","type":"post","link":"https:\/\/rarediseases.org\/es\/nord-issues-statement-on-fda-rejection-of-citizen-petition\/","title":{"rendered":"NORD Issues Statement on FDA Rejection of Citizen Petition"},"content":{"rendered":"<p><a href=\"https:\/\/rarediseases.org\/wp-content\/uploads\/2015\/07\/fda.jpg\" data-rel=\"lightbox-image-0\" data-rl_title=\"\" data-rl_caption=\"\" title=\"\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright size-full wp-image-20826\" src=\"https:\/\/rarediseases.org\/wp-content\/uploads\/2015\/07\/fda.jpg\" alt=\"fda\" width=\"286\" height=\"176\" \/><\/a>On September 10, the Food and Drug Administration (FDA) <a href=\"https:\/\/www.regulations.gov\/#!documentDetail;D=FDA-2011-P-0657-0004\" rel=\"nofollow noopener\" target=\"_blank\">notified<\/a> the National Organization for Rare Disorders (NORD) that it was rejecting NORD\u2019s Citizen Petition <a href=\"https:\/\/www.regulations.gov\/#!documentDetail;D=FDA-2011-P-0657-0001\" rel=\"nofollow noopener\" target=\"_blank\">submitted<\/a> in 2011 to request that a documented policy be established regarding the review of potential treatments for people with rare diseases.<\/p>\n<p>NORD made the request in September 2011 in conjunction with a report submitted by an FDA committee to Congress in\u00a0June 2011:\u00a0\u201cImproving the Prevention, Diagnosis and Treatment of Rare and Neglected Diseases.\u201d \u00a0In the petition, NORD expressed concern that while the FDA had demonstrated a history of flexibility in the review of \u201corphan\u201d\u2014for rare diseases\u2014products, noting that rare diseases present special challenges to researchers seeking to develop therapies, no policy then-existed specific to orphan drugs.<\/p>\n<p>NORD President and CEO Peter L. Saltonstall said, \u201cIn the time since, FDA has repeatedly demonstrated its flexibility in approving new orphan drugs.\u00a0 This flexibility was documented in a study and a follow up evaluation conducted by NORD Board member and attorney Frank Sasinowski and published in the DIA (Drug Information Association) Journal.\u00a0 NORD feels comfortable that FDA is implementing a policy of flexibility in reviewing orphan drugs, while still assuring that the drugs meets all standards for safety and effectiveness.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On September 10, the Food and Drug Administration (FDA) notified the National Organization for Rare Disorders (NORD) that it was rejecting NORD\u2019s Citizen Petition submitted in 2011 to request that &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/rarediseases.org\/es\/nord-issues-statement-on-fda-rejection-of-citizen-petition\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;NORD Issues Statement on FDA Rejection of Citizen Petition&#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],"tags":[679,244,389,243],"class_list":["post-58635","post","type-post","status-publish","format-standard","hentry","category-advocacy","tag-citizen-petition","tag-fda","tag-frank-sasinowski","tag-peter-l-saltonstall"],"acf":[],"_links":{"self":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/posts\/58635","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=58635"}],"version-history":[{"count":0,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/posts\/58635\/revisions"}],"wp:attachment":[{"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/media?parent=58635"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/categories?post=58635"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/rarediseases.org\/es\/wp-json\/wp\/v2\/tags?post=58635"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}