{"article":{"annotation":{"article_id":"fda-seeks-input-on-ibogaine-clinical-trial-design","available_at":"2026-10-06T23:11:44.175858Z","geography_revision":"ef6ee0010dda5fe7b240fd514749b43e214c57da73222d2e40ec83b276dd0977","id":"52ab9ee982f80018b206333adf325e6a7db372047f31b01a7fcb6e51bd84d8f7","input_sha256":"3bab507e90088dc2cae205f5c2641d1417323b532090efd3260f0bb046c25668","limitations":["Rule-derived subjects are candidates, not verified editorial labels or calibrated model probabilities.","Coverage is distinct from event location. 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Hasta uygunluğu, doz artışı, bakım ortamı, deneyi durdurma kuralları, güvenlik izlemi ve bağımsız denetim konularında kanıt ve görüş istiyor.","Kurum kalp ve nörolojik risklere dikkat çekti; önerilen başlangıç dozunun mevcut kanıtlarla gerekçelendirilmesini ve kilogram başına 10 miligramı aşmamasını istedi. Bu çağrı tedavi onayı değil, araştırma tasarımına ilişkin görüş talebidir; yorum süresi 20 Kasım 2026’da sona erecek."],"sections":[]},"corrections":[{"at":"2026-10-07T00:52:01+03:00","language":"tr","text":"Bu habere Almanca ve Portekizce çeviriler ile veri ve düzeltme açıklamalarının bu dillerdeki karşılıkları eklendi."}],"country":"US","data":{"blocks":[{"description":{"ar":"طلب المعلومات والموعد النهائي الواردان في بيان الإدارة.","de":"Die Informationsanfrage und die in der Mitteilung genannte Frist der FDA.","en":"The FDA information request and deadline stated in the release.","es":"La solicitud de información y el plazo indicados en el comunicado de la FDA.","fr":"La demande d’informations et l’échéance indiquées dans le communiqué de la FDA.","pt":"O pedido de informações e o prazo indicados no comunicado da FDA.","tr":"FDA’nın açıklamasındaki bilgi talebi ve kaynakta belirtilen son tarih."},"id":"ibogaine-rfi-timeline","items":[{"date":"2026-10-05","description":{"ar":"طلب آراء وبيانات بشأن تصميم تجارب الإيبوجاين المبكرة.","de":"Bitte um Stellungnahmen und Daten zur Gestaltung früher Ibogain-Studien.","en":"Request for views and data on early ibogaine trial design.","es":"Solicitud de opiniones y datos sobre ensayos iniciales de ibogaína.","fr":"Demande d’avis et de données sur les premiers essais d’ibogaïne.","pt":"Pedido de opiniões e dados sobre o desenho de estudos iniciais de ibogaína.","tr":"Erken ibogain deneylerinin tasarımı hakkında görüş ve veri çağrısı."},"label":{"ar":"إصدار طلب المعلومات","de":"FDA veröffentlicht Informationsanfrage","en":"FDA information request issued","es":"Publicación de la solicitud de información","fr":"Publication de la demande d’informations","pt":"FDA publica pedido de informações","tr":"FDA bilgi talebi yayımlandı"},"status":"occurred"},{"date":"2026-11-20","description":{"ar":"قالت الإدارة إن التعليقات المتأخرة لن تُؤخذ في الاعتبار.","de":"Laut FDA werden verspätete Stellungnahmen nicht berücksichtigt.","en":"FDA says late comments will not be considered.","es":"La FDA indica que no se considerarán comentarios tardíos.","fr":"La FDA indique que les commentaires tardifs ne seront pas pris en compte.","pt":"A FDA informa que comentários enviados após o prazo não serão considerados.","tr":"FDA, geç yorumların dikkate alınmayacağını belirtti."},"label":{"ar":"إغلاق فترة التعليقات","de":"Kommentierungsfrist endet","en":"Comment period closes","es":"Cierre del periodo de comentarios","fr":"Clôture de la période de commentaires","pt":"Fim do prazo para comentários","tr":"Yorum süresinin kapanması"},"status":"scheduled"}],"methodology":{"ar":"نُقل التاريخ ووصف الإجراء عن بيان الإدارة؛ والموعد المستقبلي محدد في المصدر ولا يعني اعتماد دواء أو نتيجة تجربة.","de":"Datum und Maßnahme wurden von der FDA übernommen. Die künftige Frist stammt aus der Quelle und bedeutet weder eine Arzneimittelzulassung noch ein Studienergebnis.","en":"The date and action are transcribed from FDA. The future deadline is source-stated and does not indicate a drug approval or trial result.","es":"La fecha y el procedimiento proceden de la FDA. El plazo futuro lo fija la fuente y no implica aprobación de un fármaco ni resultado de un ensayo.","fr":"La date et la démarche sont reprises de la FDA. L’échéance future est indiquée par la source et ne signale ni autorisation de médicament ni résultat d’essai.","pt":"A data e a medida foram transcritas da FDA. O prazo futuro é informado pela fonte e não indica aprovação de medicamento nem resultado de estudo.","tr":"Tarih ve işlem açıklaması FDA duyurusundan aktarılmıştır; gelecekteki son tarihi kaynak belirtir ve ilaç onayı ya da deney sonucu anlamına gelmez."},"sourceUrls":["https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research"],"title":{"ar":"طلب المعلومات وجدول التعليقات لدى الإدارة","de":"Informationsanfrage der FDA und Frist für Stellungnahmen","en":"FDA information request and comment timeline","es":"Solicitud de información de la FDA y plazo de comentarios","fr":"Demande d’informations de la FDA et calendrier des commentaires","pt":"Pedido de informações da FDA e prazo para comentários","tr":"FDA bilgi talebi ve yorum takvimi"},"type":"events","updatedAt":"2026-10-07T00:52:01+03:00"}],"version":1},"data_downloads":[{"formats":{"csv":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design/data/ibogaine-rfi-timeline?lang=tr&format=csv","json":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design/data/ibogaine-rfi-timeline?lang=tr&format=json"},"id":"ibogaine-rfi-timeline"}],"data_types":["events"],"editorial_illustration":{"alt":"Halk sağlığı, araştırma ve bağlantılı verinin kavramsal illüstrasyonu.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"tr","scope":"topic","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"event_id":"event-87987f42-68ad-5dee-89b2-ce35761b96ee","event_period":"2026-10-05","event_period_basis":"event-or-reference-period","id":"fda-seeks-input-on-ibogaine-clinical-trial-design","image":null,"importance":0.6,"language":"tr","modified_at":"2026-10-07T00:52:01+03:00","publication_basis":"publication-record","published_at":"2026-10-06T17:58:49+00:00","reading_minutes":1,"region":"world","section_illustration":{"alt":"Halk sağlığı, araştırma ve bağlantılı verinin kavramsal illüstrasyonu.","asset_id":"newsverum-v1-health","avif_variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.avif","width":480},{"height":480,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-720.avif","width":720},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.avif","width":960},{"height":800,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1200.avif","width":1200},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.avif","width":1536}],"credit":"Newsverum","documentary":false,"height":1024,"kind":"symbolic-editorial-illustration","language":"tr","scope":"section","url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","variants":[{"height":320,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-480.webp","width":480},{"height":640,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-960.webp","width":960},{"height":1024,"url":"https://newsverum.com/assets/newsverum/illustrations/v1/health-1536.webp","width":1536}],"width":1536},"slug":"fda-seeks-input-on-ibogaine-clinical-trial-design","sources":[{"checkedAt":"2026-10-06","name":"U.S. Food and Drug Administration","publishedAt":"2026-10-05","url":"https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research"}],"summary":"Kurum; çalışma tasarımı, doz, güvenlik izlemi ve denetim konularında görüş talep ediyor; son tarih 20 Kasım.","text":"Kurum; çalışma tasarımı, doz, güvenlik izlemi ve denetim konularında görüş talep ediyor; son tarih 20 Kasım.\n\nFDA, ibogain ürünleri için erken aşama klinik deneylerin nasıl tasarlanması gerektiğine ilişkin bilgi talebi yayımladı. Hasta uygunluğu, doz artışı, bakım ortamı, deneyi durdurma kuralları, güvenlik izlemi ve bağımsız denetim konularında kanıt ve görüş istiyor.\n\nKurum kalp ve nörolojik risklere dikkat çekti; önerilen başlangıç dozunun mevcut kanıtlarla gerekçelendirilmesini ve kilogram başına 10 miligramı aşmamasını istedi. Bu çağrı tedavi onayı değil, araştırma tasarımına ilişkin görüş talebidir; yorum süresi 20 Kasım 2026’da sona erecek.\n\nBu habere Almanca ve Portekizce çeviriler ile veri ve düzeltme açıklamalarının bu dillerdeki karşılıkları eklendi.","title":"FDA, ibogainin erken klinik deneylerindeki güvenlik önlemleri için görüş istiyor","topics":[],"translations":[{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=tr","language":"tr","url":"https://newsverum.com/tr/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=en","language":"en","url":"https://newsverum.com/en/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=ar","language":"ar","url":"https://newsverum.com/ar/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=fr","language":"fr","url":"https://newsverum.com/fr/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=es","language":"es","url":"https://newsverum.com/es/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=de","language":"de","url":"https://newsverum.com/de/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},{"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=pt","language":"pt","url":"https://newsverum.com/pt/news/fda-seeks-input-on-ibogaine-clinical-trial-design"}],"url":"https://newsverum.com/tr/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},"version":"1"}