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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
Review and Update of Device Establishment Inspection Processes and Standards: Guidance for Industry  Food and Drug Administration (FDA) Final
Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates: Guidance for Industry  Food and Drug Administration (FDA) Final
Revised Recommendations Regarding Invalidation of Test Results of Licensed and 510(k) Cleared Bloodborne Pathogen Assays Used to Test Donors: Guidance for Industry  Food and Drug Administration (FDA) Final
Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS: Guidance for Industry  Food and Drug Administration (FDA) Final
S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals: Guidance for Industry  Food and Drug Administration (FDA) Final
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals : Guidance for Industry  Food and Drug Administration (FDA) Final
S6(R1) Addendum: Preclinical Safety Evaluation of Biotechnology: Guidance for Industry  Food and Drug Administration (FDA) Final
Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency: Guidance for Industry  Food and Drug Administration (FDA) Final
Section 503A Bulks List Final Rule Questions and Answers; Small Entity Compliance Guide;: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.