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HHS Guidance Submissions

HHS Guidance

* Metadata including document title and file name are searchable, however, the contents of the guidance documents that are not in HTML format are currently not keyword searchable.

Title OpDiv/StaffDiv 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
This Guidance Portal contains 41537 documents.

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