Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment; Guidance for Industry; Availability
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Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment." This guidance is intended to assist sponsors in the clinical development of drugs and biological products for the treatment of acute myeloid leukemia (AML). This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for the development of drugs and biological products to support an indication of treatment of AML, including indications limited to an individual phase of treatment (for example, maintenance, transplantation preparative regimen, etc.). The guidance addresses the topics of general drug development, efficacy endpoints, and exploratory and confirmatory trial considerations for AML drug development. In addition, the guidance addresses investigational new drug applications, new drug applications, and biologics licensing applications for AML drugs. This guidance finalizes the draft guidance of the same title "Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment" issued August 2020.
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