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GUIDANCE DOCUMENT

Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias Guidance for Industry Technical Specifications Document October 2025

Download the Final Guidance Document
Final
Docket Number:
FDA-2018-D-1216
Issued by:
Guidance Issuing Office
Oncology Center of Excellence
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This document provides technical recommendations for the data sets containing the data elements for response assessments and summary level response outcomes used to evaluate efficacy in clinical trials of drugs and biological products submitted to the U.S. Food and Drug Administration (FDA) in New Drug Applications (NDAs) and Biologics License Applications (BLAs) for treatment of acute leukemias. The specifications provided herein complement rather than supplant the clinical development program and efficacy endpoint recommendations in disease-specific guidances. Additionally, the scope of these technical recommendations is limited to data elements specific to efficacy evaluations for acute leukemias; for general recommendations on submission of standardized study data, see the Study Data Technical Conformance Guide.

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All written comments should be identified with this document's docket number: FDA-2018-D-1216.

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