# Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/recommended-followup-testing-for-an-ames-positive-drug-active-ingredient-or-metabolite-to-support-first-in-human-clinical-trials-with-healthy-subjects/ce4cb94e-e7a9-4c9d-a289-a55bc94e74c1

> FDA guidance document: Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects. Issue date: November 27, 2024. Get complete insights and analysis.

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## Details

- Title: Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2024-11-27
- Comment Close Date: 2025-02-25
- Last Changed: 2024-11-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2024-D-4540">FDA-2024-D-4540</a>

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