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GUIDANCE DOCUMENT

Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects November 2024

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2024-D-4540
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Recommended Followup Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Human Clinical Trials With Healthy Subjects.” This draft guidance makes recommendations on followup testing for Ames-positive active ingredients in circumstances when a sponsor decides to continue development. The guidance recommends a consistent process of followup testing and evaluation that first should be conducted for an Ames-positive active ingredient before proceeding with first-in-human (FIH) trials in healthy human subjects. These recommendations are intended to potentially help address and lower safety concerns before proceeding with FIH trials in healthy human subjects.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-D-4540.

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