{"id":8660,"date":"2022-05-03T12:59:33","date_gmt":"2022-05-03T16:59:33","guid":{"rendered":"http:\/\/localhost:10028\/uncategorized\/what-does-fda-approved-really-mean\/"},"modified":"2022-08-18T21:16:04","modified_gmt":"2022-08-19T01:16:04","slug":"fda-onayli-gercekten-ne-anlama-geliyor","status":"publish","type":"post","link":"https:\/\/napolilaw.lemonadestand.org\/tr\/article\/fda-onayli-gercekten-ne-anlama-geliyor\/","title":{"rendered":"&quot;FDA Onayl\u0131&quot; Ger\u00e7ekten Ne Anlama Geliyor?"},"content":{"rendered":"<p><span style=\"font-weight: 400;\">Bir \u00fcr\u00fcnde &quot;FDA onayl\u0131&quot; ibaresini g\u00f6rd\u00fc\u011f\u00fcn\u00fczde, bunun devlet kurumu taraf\u0131ndan g\u00fcvenli ve etkili oldu\u011funun do\u011fruland\u0131\u011f\u0131n\u0131 d\u00fc\u015f\u00fcnmek kolayd\u0131r. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ama bu ger\u00e7ekten ne anlama geliyor?<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Bu yaz\u0131da, \u201cFDA onayl\u0131\u201d ifadesinin ger\u00e7ekte ne anlama geldi\u011finin yan\u0131 s\u0131ra bir \u00fcr\u00fcn\u00fcn, \u00f6zellikle farmas\u00f6tiklerin FDA onayl\u0131 olma s\u00fcrecini tart\u0131\u015faca\u011f\u0131z. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">S\u00fcreci ve &quot;FDA onayl\u0131&quot;n\u0131n ger\u00e7ekte ne anlama geldi\u011fini anlamak, FDA onayl\u0131 bir \u00fcr\u00fcnden zarar g\u00f6r\u00fcp g\u00f6rmedi\u011finizi belirlemenize yard\u0131mc\u0131 olabilir.<\/span><\/p>\n<h2><b>\u0130la\u00e7lar FDA Onay\u0131n\u0131 Nas\u0131l Al\u0131r?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">Bir ilac\u0131n Amerika Birle\u015fik Devletleri&#039;nde pazarlanabilmesi i\u00e7in \u00f6nce FDA ile titiz bir onay s\u00fcrecinden ge\u00e7mesi gerekir. FDA&#039;n\u0131n, bir ilac\u0131n onaylanabilmesi i\u00e7in kar\u015f\u0131lanmas\u0131 gereken bir tak\u0131m gereklilikleri vard\u0131r, bunlar aras\u0131nda:<\/span><\/p>\n<ul>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0130la\u00e7 g\u00fcvenli ve etkili olmal\u0131d\u0131r.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0130la\u00e7, iyi \u00fcretim uygulamalar\u0131na (GMP&#039;ler) g\u00f6re \u00fcretilmelidir. GMP&#039;ler, ila\u00e7lar\u0131n g\u00fcvenli bir \u015fekilde ve kalite standartlar\u0131na g\u00f6re yap\u0131lmas\u0131n\u0131 sa\u011flayan bir dizi d\u00fczenlemedir.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0130la\u00e7 uygun \u015fekilde etiketlenmelidir. Etiket, ilac\u0131n ad\u0131n\u0131, dozaj\u0131n\u0131 ve kullan\u0131m talimatlar\u0131n\u0131 i\u00e7ermelidir. Etiket ayr\u0131ca olas\u0131 riskler ve yan etkiler konusunda da uyarmal\u0131d\u0131r.<\/span><\/li>\n<li style=\"font-weight: 400;\" aria-level=\"1\"><span style=\"font-weight: 400;\">\u0130laca bir hasta prospekt\u00fcs\u00fc (PPI) e\u015flik etmelidir. \u00dcFE, hastalara ila\u00e7 hakk\u0131nda bilgi veren bir belgedir. \u0130lac\u0131n kullan\u0131mlar\u0131, potansiyel riskleri, yan etkileri ve nas\u0131l al\u0131naca\u011f\u0131 hakk\u0131nda bilgiler i\u00e7erir.<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Yeni bir ilac\u0131n pazara sunulabilmesi i\u00e7in, \u00fcreticinin FDA&#039;ya ara\u015ft\u0131rma ama\u00e7l\u0131 yeni ila\u00e7 ba\u015fvurusu (IND) sunmas\u0131 gerekir. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">IND, yeni bir ilac\u0131 insanlarda test etmek i\u00e7in izin talebidir. FDA ba\u015fvuruyu inceleyecek ve daha fazla bilgi isteyebilir.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA, \u00fcreticinin ilac\u0131 test etmesine izin verirse, ila\u00e7 klinik beklemeye al\u0131n\u0131r. Klinik bekletme, FDA&#039;n\u0131n g\u00fcvenlik endi\u015feleri nedeniyle bir klinik ara\u015ft\u0131rmay\u0131 durdurmas\u0131d\u0131r.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00dcretici ayr\u0131ca FDA&#039;ya yeni bir ila\u00e7 ba\u015fvurusu (NDA) sunmal\u0131d\u0131r. NDA, klinik \u00f6ncesi ve klinik \u00e7al\u0131\u015fmalardan elde edilen verileri i\u00e7eren, ilaca ili\u015fkin kapsaml\u0131 bir rapordur. FDA NDA&#039;y\u0131 inceleyecek ve daha fazla bilgi isteyebilir.\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA, \u00fcreticinin ilac\u0131 satmas\u0131na izin verirse, ila\u00e7, nihai onay beklemesi olarak adland\u0131r\u0131lan duruma konulacakt\u0131r. Son onay beklemesi, FDA&#039;n\u0131n g\u00fcvenlik endi\u015feleri nedeniyle bir ilac\u0131n sat\u0131\u015f\u0131n\u0131 durdurmas\u0131d\u0131r.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Yeni bir ilac\u0131n onay s\u00fcreci uzun y\u0131llar alabilir. FDA, onay s\u00fcrecinde herhangi bir zamanda \u00fcreticiden daha fazla bilgi talep edebilir.<\/span><\/p>\n<h2><b>&quot;FDA Onayl\u0131&quot; Ne Demektir?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">D\u00f6nem &quot;<\/span><a href=\"https:\/\/www.fda.gov\/consumers\/consumer-updates\/it-really-fda-approved\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">FDA onayl\u0131<\/span><\/a><span style=\"font-weight: 400;\">&quot;, G\u0131da ve \u0130la\u00e7 \u0130daresi (FDA) taraf\u0131ndan onaylanan \u00fcr\u00fcnleri tan\u0131mlamak i\u00e7in kullan\u0131l\u0131r. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ama bu ne anlama geliyor? \u00c7o\u011fu durumda, \u00fcreticinin \u00fcr\u00fcnle ilgili bilgileri FDA&#039;ya sundu\u011fu ve pazarlanmas\u0131 i\u00e7in onay ald\u0131\u011f\u0131 anlam\u0131na gelir. <\/span><\/p>\n<p><b>FDA asl\u0131nda \u00fcr\u00fcnleri kendisi test etmez; \u00fcreticiler taraf\u0131ndan sa\u011flanan verilere dayan\u0131r.<\/b><\/p>\n<h2><b>Ya FDA Onayl\u0131 Bir \u00dcr\u00fcnden Zarar G\u00f6r\u00fcrseniz?<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">FDA onayl\u0131 bir \u00fcr\u00fcnden zarar g\u00f6rd\u00fcyseniz, \u015funlar\u0131 yapabilirsiniz:<\/span><a href=\"\/tr\/uygulama-alanlari-2\/ilac-davasi\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\"> dava a\u00e7mak<\/span><\/a><span style=\"font-weight: 400;\"> \u00fcreticiye kar\u015f\u0131. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">FDA&#039;n\u0131n, bir ilac\u0131n pazara sunulmas\u0131ndan \u00f6nce uyulmas\u0131 gereken bir dizi g\u00fcvenlik d\u00fczenlemesi vard\u0131r ve \u00fcreticiler bu d\u00fczenlemelere uymakla y\u00fck\u00fcml\u00fcd\u00fcr. <\/span><\/p>\n<p><span style=\"font-weight: 400;\">Aksi takdirde, \u00fcr\u00fcnlerinden kaynaklanan herhangi bir yaralanmadan sorumlu tutulabilirler.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\u00dcreticinin yanl\u0131\u015f iddialarda bulunmas\u0131na veya ilac\u0131 almak i\u00e7in uygun talimatlar\u0131n verilmemesine ba\u011fl\u0131 olarak farkl\u0131 taraflar sorumlu olabilir.<\/span><\/p>\n<h2><b>\u0130leti\u015fim Napoli Shkolnik<\/b><\/h2>\n<p><span style=\"font-weight: 400;\">FDA onayl\u0131 bir \u00fcr\u00fcnden zarar g\u00f6rd\u00fcyseniz, bir davan\u0131z olup olmad\u0131\u011f\u0131n\u0131 belirlemenize yard\u0131mc\u0131 olabilecek bir avukatla konu\u015fman\u0131z \u00f6nemlidir. <\/span><a href=\"\/tr\/bize-ulasin\/\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400;\">Napoli Shkolnik&#039;in ekibiyle ileti\u015fime ge\u00e7in<\/span><\/a><span style=\"font-weight: 400;\"> \u00fccretsiz, ba\u011flay\u0131c\u0131 olmayan bir dan\u0131\u015fmanl\u0131k i\u00e7in bug\u00fcn profesyonellerden.<\/span><\/p>","protected":false},"excerpt":{"rendered":"<p>Bir \u00fcr\u00fcnde &quot;FDA onayl\u0131&quot; ibaresini g\u00f6rd\u00fc\u011f\u00fcn\u00fczde, bunun devlet kurumu taraf\u0131ndan g\u00fcvenli ve etkili oldu\u011funun do\u011fruland\u0131\u011f\u0131n\u0131 d\u00fc\u015f\u00fcnmek kolayd\u0131r. Ama bu ger\u00e7ekten ne yapar\u2026<\/p>","protected":false},"author":3,"featured_media":8661,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[776],"tags":[964,971,972],"class_list":["post-8660","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceutical-litigation","tag-personal-injury","tag-health-and-safety","tag-fda-recall"],"acf":[],"page_builder_type":"gutenberg","gutenberg_data":[],"_links":{"self":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/8660","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/comments?post=8660"}],"version-history":[{"count":0,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/posts\/8660\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media\/8661"}],"wp:attachment":[{"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/media?parent=8660"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/categories?post=8660"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/napolilaw.lemonadestand.org\/tr\/wp-json\/wp\/v2\/tags?post=8660"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}