{"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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Elle sollicite des données et des avis sur l’admissibilité des patients, l’escalade des doses, le cadre de soins, les règles d’arrêt, la surveillance de la sécurité et la supervision indépendante.","L’agence a signalé des risques cardiaques et neurologiques et indiqué que la dose initiale proposée devait être justifiée par les données disponibles et ne pas dépasser 10 milligrammes par kilogramme. Cette consultation porte sur la conception de la recherche et ne constitue pas une autorisation de traitement ; la période de commentaires doit prendre fin le 20 novembre 2026."],"sections":[]},"corrections":[{"at":"2026-10-07T00:52:01+03:00","language":"fr","text":"Des éditions allemande et portugaise, ainsi que les traductions des explications des données et des corrections, ont été ajoutées à cet article."}],"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=fr&format=csv","json":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design/data/ibogaine-rfi-timeline?lang=fr&format=json"},"id":"ibogaine-rfi-timeline"}],"data_types":["events"],"editorial_illustration":{"alt":"Illustration conceptuelle de la santé publique, de la recherche et des données connectées.","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":"fr","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":"fr","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":"Illustration conceptuelle de la santé publique, de la recherche et des données connectées.","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":"fr","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":"L’agence interroge le public sur le protocole, les doses, la surveillance et le contrôle, avec des commentaires attendus avant le 20 novembre.","text":"L’agence interroge le public sur le protocole, les doses, la surveillance et le contrôle, avec des commentaires attendus avant le 20 novembre.\n\nLa FDA a publié une demande d’informations sur la conception des premiers essais cliniques de produits à base d’ibogaïne. 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Cette consultation porte sur la conception de la recherche et ne constitue pas une autorisation de traitement ; la période de commentaires doit prendre fin le 20 novembre 2026.\n\nDes éditions allemande et portugaise, ainsi que les traductions des explications des données et des corrections, ont été ajoutées à cet article.","title":"La FDA sollicite des avis sur la sécurité des premiers essais de l’ibogaïne","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/fr/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},"version":"1"}