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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
Basic Health Program; Federal Funding Methodology for Program Year 2026  Centers for Medicare & Medicaid Services (CMS) Final
2026 SSI, Spousal Impoverishment, and Medicare Savings Program Resource Standards  Centers for Medicare & Medicaid Services (CMS) Final
Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing  Food and Drug Administration (FDA) Proposed
Bioanalytical Method Validation for Biomarkers  Food and Drug Administration (FDA) Final
General Considerations for the Use of New Approach Methodologies in Drug Development  Food and Drug Administration (FDA) Proposed
Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection  Food and Drug Administration (FDA) Proposed
New Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers  Food and Drug Administration (FDA) Proposed
"Working Families Tax Cut” Legislation, Public Law 119-21: Summary of Medicaid and Children's Health Insurance Program (CHIP) Related Provisions  Centers for Medicare & Medicaid Services (CMS) Final
Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 10238 documents.