Docket Number:
FDA-2020-D-1298
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

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.).

For questions regarding this draft document, contact (CDER) Donna Przepiorka at 301-796-5358 or Donna.Przepiorka@fda.hhs.gov, or (CBER) Office of Communication, Outreach and Development at 800-835-4709 or 240-402-8010.

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All written comments should be identified with this document's docket number: FDA-2020-D-1298.