Diese Übersetzung wird noch vorbereitet. Bis dahin zeigen wir vorübergehend die englische Originalversion.
Geschäft · 2.3.20221 Min. Lesezeit
Expansion Cohorts: Use in First-in-Human Clinical Trials To Expedite Development of Oncology Drugs and Biologics; Guidance for Industry; Availability
Lokale automatische Übersetzung · Originalsprache der Quelle
Zusammenfassung
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Expansion Cohorts: Use in First-in-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics." The purpose of this guidance is to provide advice to sponsors regarding the design and conduct of first- in-human (FIH) clinical trials intended to efficiently expedite the clinical development of oncology drugs, including biological products, through multiple expansion cohort trial designs. This guidance finalizes the draft guidance of the same name issued in August 2018.
Originalsprache der Quelle: Federal Register — Food and Drug AdministrationOriginalquelle öffnen →