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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
Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide (Revised): Guidance for Industry  Food and Drug Administration (FDA) Final
Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Residual Drug in Transdermal and Related Drug Delivery Systems: Guidance for Industry  Food and Drug Administration (FDA) Final
Residual Solvents in Drug Products Marketed in the United States: Guidance for Industry  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4735 documents.