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In this section: Drug Development Tool (DDT) Qualification Programs

Guidance Documents (DDT)

Use of Histology in Biomarker Qualification Studies
E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (final)
Product Development Under the Animal Rule

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