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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
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing  Food and Drug Administration (FDA) Proposed
Establishing Impurity Specifications for Antibiotics  Food and Drug Administration (FDA) Proposed
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for Industry  Food and Drug Administration (FDA) Final
Submitting Continuous Glucose Monitoring Data in Clinical Trials  Food and Drug Administration (FDA) Final
Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization  Food and Drug Administration (FDA) Final
Continuation of System Changes to Automate Processing of Inpatient Claims for Chimeric Antigen Receptor (CAR) T-Cell and Other Immunotherapy Cases   Centers for Medicare & Medicaid Services (CMS) Final
2026 Annual Update of Per-Beneficiary Threshold Amounts   Centers for Medicare & Medicaid Services (CMS) Final
Medicare Prescription Payment Plan Update on 2026 Model Documents G  Centers for Medicare & Medicaid Services (CMS) Final
PDE Inbound File Layout Effective 01012026 G  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 5543 documents.