Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment

On 17 October 2022 the FDA published the final guidance on acute myeloid leukemia treatment for industry.

The purpose of this guidance is to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). 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 AML, including indications limited to an individual phase of treatment (e.g., maintenance, transplantation preparative regimen, etc.).

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