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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
Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Federal Fiscal Year 2026 Updates to the Health Home Core Quality Measure Sets  Centers for Medicare & Medicaid Services (CMS) Final
Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Unique Device Identifier Requirements for Combination Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q1 Stability Testing of Drug Substances and Drug Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
cib06052025  Centers for Medicare & Medicaid Services (CMS) Final
Hernia Mesh – Package Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 11397 documents.