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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
S2A Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals  Food and Drug Administration (FDA) Final
S2B Genotoxicity: A Standard Battery for Genotoxicity Testing of Pharmaceuticals  Food and Drug Administration (FDA) Final
S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling  Food and Drug Administration (FDA) Final
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies  Food and Drug Administration (FDA) Final
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies  Food and Drug Administration (FDA) Final
S4A Duration of Chronic Toxicity Testing in Animals (Rodent and Nonrodent Toxicity Testing)  Food and Drug Administration (FDA) Final
S5A Detection of Toxicity to Reproduction for Medicinal Products S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined  Food and Drug Administration (FDA) Final
S5B Detection of Toxicity to Reproduction for Medicinal Products: S5(R2) Detection of Toxicity to Reproduction for Medicinal Products Toxicity to Male Fertility In November 2005, the ICH incorporated the S5B addendum with S5A and retitled the combined  Food and Drug Administration (FDA) Final
S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals  Food and Drug Administration (FDA) Final
S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals  Food and Drug Administration (FDA) Final
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