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Regulatory Guidances List: Alternative Methods

FDA guidances that include use of alternative methods approaches. The list below is current and updated regularly.

Regulatory Guidances

ICH S10 Photosafety Evaluation of Pharmaceuticals Guidance for Industry, 2015 – Use of in chemico and in vitro approaches to assess phototoxicity potential.

ICH S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals Guidance for Industry, 2021 – Description of testing strategies utilizing alternative assays for the assessment of malformations and embryofetal lethality, and the qualification process for these alternative assays.

ICH M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk Guidance for Industry, 2018 – Use of computational approaches for the assessment of mutagenic potential of drug impurities.

ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling Questions and Answers Guidance for Industry, 2018 – Use of microsampling in toxicity studies.

Oncology Pharmaceuticals: Reproductive Toxicity Testing and Labeling Recommendations Guidance for Industry, 2019 – Potential use of alternative assays, such as fit-for-purpose in vitro or ex vivo, or nonmammalian in vivo assays for assessment of reproductive toxicity.

Resources for You

Advancing Alternative Methods at FDA

FDA's Predictive Toxicology Roadmap

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