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# Acute Myeloid Leukemia Drug Development Guide
- URL: https://www.fdaweb.com/acute-myeloid-leukemia-drug-development-guide/
- Published: 2020-08-13T12:00:00.000Z
- Updated: 2026-09-14T16:24:51.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147423

*Federal Register* notice: FDA has made available a draft guidance on “Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment.” The document addresses FDA’s current thinking on the overall development program and clinical trial designs for developing drugs and biological products to support an indication for treating AML, including indications limited to an individual treatment phase (e.g., maintenance, transplantation preparative regimen, etc.). To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-08-13/pdf/2020-17714.pdf?ref=fdaweb.com).