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HHS Guidance Submissions

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Title OpDiv/StaffDiv Sort descending Guidance Status Issue Date
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
S7A Safety Pharmacology Studies for Human Pharmaceuticals  Food and Drug Administration (FDA) Final
S7B Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals  Food and Drug Administration (FDA) Final
S8 Immunotoxicity Studies for Human Pharmaceuticals  Food and Drug Administration (FDA) Final
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals  Food and Drug Administration (FDA) Final
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