{"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. Unknown country/city/coordinates remain absent; no automatic geocoding.","Article geometries keep their stated precision and methodology; reproducing them is not independent coordinate verification."],"method":"controlled-rules-v1","places":[{"admin1":null,"city":null,"coordinate_note":null,"coordinate_reference_system":"OGC:CRS84","coordinate_source":null,"country":"US","evidence":[{"field":"country","language":"en","note":"Explicit preserved editorial country/region; no city or national centroid inferred","source_urls":["https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research"]}],"geometry":null,"id":"iso3166-1:US","kind":"country-or-area","labels":{"ar":"الولايات المتحدة الأمريكية","en":"United States of America","es":"Estados Unidos de América","fr":"États-Unis d’Amérique"},"match_status":"candidate","precision":"regional","role":"coverage","uncertainty_m":null}],"rules_sha256":"d28c9c89703b56bd91fd887965d416d0115c2473d4bfbd3e558bcceafc3941dd","schema_version":1,"subjects":[{"concept_id":"medtop:07000000","confidence":null,"confidence_method":null,"evidence":[{"field":"category+topics","language":"en","note":"Preserved editorial category/topic; broad candidate only","source_urls":["https://www.fda.gov/news-events/press-announcements/fda-seeks-public-input-support-ibogaine-research"]}],"method":"controlled-rules-v1","rule_id":"health-broad","status":"candidate"}],"taxonomy_revision":"1f2db31d811fca07e99b16d402c10e2cc2965c9df1c7b41d9be348b40a24e7fb","taxonomy_version":"IPTC Media Topics 2026-Q2"},"api_url":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design?lang=de","category":"health","content":{"key_points":[],"paragraphs":["Die FDA veröffentlichte eine Informationsanfrage dazu, wie frühe klinische Studien zu Ibogain-Produkten gestaltet werden sollten. Sie bittet um Evidenz und Rückmeldungen zu Teilnahmebedingungen, Dosiseskalation, Versorgungsumgebung, Abbruchregeln, Sicherheitsüberwachung und unabhängiger Aufsicht.","Die Behörde hob kardiale und neurologische Risiken hervor und erklärte, eine vorgeschlagene Anfangsdosis müsse durch verfügbare Evidenz gestützt werden und dürfe 10 Milligramm pro Kilogramm nicht überschreiten. Die Anfrage betrifft die Gestaltung der Forschung und ist keine Zulassung einer Ibogain-Behandlung; die Kommentierungsfrist soll am 20. November 2026 enden."],"sections":[]},"corrections":[{"at":"2026-10-07T00:52:01+03:00","language":"de","text":"Dieser Artikel wurde um eine deutsche und eine portugiesische Ausgabe sowie entsprechende Übersetzungen der Daten- und Korrekturhinweise ergänzt."}],"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=de&format=csv","json":"https://newsverum.com/api/v1/articles/fda-seeks-input-on-ibogaine-clinical-trial-design/data/ibogaine-rfi-timeline?lang=de&format=json"},"id":"ibogaine-rfi-timeline"}],"data_types":["events"],"editorial_illustration":{"alt":"Konzeptionelle Darstellung von öffentlicher Gesundheit, Forschung und vernetzten Daten.","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":"de","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":"de","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":"Konzeptionelle Darstellung von öffentlicher Gesundheit, Forschung und vernetzten Daten.","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":"de","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":"Die Behörde fragt nach Studiendesign, Dosierung, Sicherheitsüberwachung und Aufsicht; Stellungnahmen sind bis zum 20. November möglich.","text":"Die Behörde fragt nach Studiendesign, Dosierung, Sicherheitsüberwachung und Aufsicht; Stellungnahmen sind bis zum 20. November möglich.\n\nDie FDA veröffentlichte eine Informationsanfrage dazu, wie frühe klinische Studien zu Ibogain-Produkten gestaltet werden sollten. Sie bittet um Evidenz und Rückmeldungen zu Teilnahmebedingungen, Dosiseskalation, Versorgungsumgebung, Abbruchregeln, Sicherheitsüberwachung und unabhängiger Aufsicht.\n\nDie Behörde hob kardiale und neurologische Risiken hervor und erklärte, eine vorgeschlagene Anfangsdosis müsse durch verfügbare Evidenz gestützt werden und dürfe 10 Milligramm pro Kilogramm nicht überschreiten. Die Anfrage betrifft die Gestaltung der Forschung und ist keine Zulassung einer Ibogain-Behandlung; die Kommentierungsfrist soll am 20. November 2026 enden.\n\nDieser Artikel wurde um eine deutsche und eine portugiesische Ausgabe sowie entsprechende Übersetzungen der Daten- und Korrekturhinweise ergänzt.","title":"FDA bittet um Stellungnahmen zu Schutzmaßnahmen bei frühen Ibogain-Studien","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/de/news/fda-seeks-input-on-ibogaine-clinical-trial-design"},"version":"1"}