Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias: Guidance for Industry Technical Specifications Document
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
October 14, 2025
October 14, 2025
fcae5d52-07e3-4b70-a7d3-d72bbe4ba316
Related Documents
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
Guidance DocumentJune 18, 2026Center for Drug Evaluation and Research
Submitting Clinical Trial Datasets and Documentation for Clinical Outcome Assessments Using Item Response Theory
Guidance DocumentNovember 6, 2023Center for Drug Evaluation and Research
Submitting Patient-Reported Outcome Data in Cancer Clinical Trials
Guidance DocumentNovember 6, 2023Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Stay ahead of FDA enforcement
New KeyPedia insights, webinars, and regulatory analysis — straight to your inbox. Unsubscribe anytime.