An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

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

Top