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# Leukemia Treatment Data Sets Guidance
- URL: https://www.fdaweb.com/leukemia-treatment-data-sets-guidance/
- Published: 2025-10-14T12:00:00.000Z
- Updated: 2026-09-14T15:24:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160038

FDA has published a guidance, *Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias*, with recommendations for data sets containing elements for response assessments and summary level response outcomes used to evaluate efficacy in clinical trials of drugs and biological products submitted to FDA in NDAs and BLAs to treat acute leukemias. The [document](https://www.fda.gov/media/189220/download?ref=fdaweb.com) says its specifications complement rather than supplant the clinical development program and efficacy endpoint recommendations in disease-specific guidelines.

It says the scope of the technical recommendations is limited to data elements specific to efficacy evaluations for acute leukemias.

The guidance contains a Table of Contents, Introduction, Overview of the Data Model Concept, Dataset Specifications, and two Appendices.