> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Guide on Drug Development Qualification Tools
- URL: https://www.fdaweb.com/guide-on-drug-development-qualification-tools/
- Published: 2020-11-25T12:00:00.000Z
- Updated: 2026-09-14T16:38:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148166

*Federal Register* notice: FDA has made available a final guidance entitled *Qualification Process for Drug Development Tools*. The process was mandated in the 21st Century Cures Act, which defined a three-stage qualification process for drug development tools. The guidance outlines the new qualification process and transparency requirements, and discusses the taxonomy for biomarkers and other development tools. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-11-25/pdf/2020-26051.pdf?ref=fdaweb.com).