> ## 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.

# Follow-up Testing for Ames-Positive Drugs Guide
- URL: https://www.fdaweb.com/follow-up-testing-for-ames-positive-drugs-guide-2/
- Published: 2024-11-27T12:00:00.000Z
- Updated: 2026-09-14T14:48:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5158272

*Federal Register* notice: FDA is making available a draft guidance entitled “Recommended Follow-up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects.” The document provides recommendations on follow-up testing for Ames-positive active ingredients in circumstances when a sponsor decides to continue development. It recommends a consistent process of follow-up testing and evaluation that first should be conducted for an active ingredient before proceeding with first-in-human trials in healthy human subjects. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-11-27/pdf/2024-27796.pdf?ref=fdaweb.com).