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HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
S10 Photosafety Evaluation of Pharmaceuticals  Food and Drug Administration (FDA) Final
S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Final
S1B Testing for Carcinogenicity of Pharmaceuticals  Food and Drug Administration (FDA) Final
S1C(R2) Dose Selection for Carcinogenicity Studies of Pharmaceuticals  Food and Drug Administration (FDA) Final
S2(R1) Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4735 documents.