17 August 2020 - The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukaemia. 

Specifically, this guidance addresses FDA’s current thinking regarding the overall development program and clinical trial designs for the development of drugs to support an indication of treatment of patients with acute myeloid leukaemia, including indications limited to an individual phase of treatment (e.g., maintenance, transplantation preparative regimen, etc.).

Read FDA Guidance