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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
Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug  Food and Drug Administration (FDA) Final
Forms FDA 3542a and FDA 3542: Questions and Answers  Food and Drug Administration (FDA) Proposed
Budget Neutrality and Certification by the Chief Actuary of CMS for Section 1115 Medicaid Demonstration Projects (SMD 26-003)  Centers for Medicare & Medicaid Services (CMS) Final
Certain Postapproval Requirements and Resources for ANDAs  Food and Drug Administration (FDA) Final
MM14464 - ICD-10 & Other Coding Revisions to National Coverage Determinations: October 2026 Update  Centers for Medicare & Medicaid Services (CMS) Final
Interim Final Rule with Comment Period: Medicaid Program; Community Engagement Requirement for Certain Individuals (CMS-2454-IFC)  Centers for Medicare & Medicaid Services (CMS) Final
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing  Food and Drug Administration (FDA) Proposed
Q8, Q9, and Q10 Questions and Answers (R5)  Food and Drug Administration (FDA) Final
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Draft Guidance  Food and Drug Administration (FDA) Proposed
Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 8098 documents.