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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
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing  Food and Drug Administration (FDA) Proposed
Interim Final Rule with Comment Period: Medicaid Program; Community Engagement Requirement for Certain Individuals (CMS-2454-IFC)  Centers for Medicare & Medicaid Services (CMS) Final
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Draft Guidance  Food and Drug Administration (FDA) Proposed
Q8, Q9, and Q10 Questions and Answers (R5)  Food and Drug Administration (FDA) Final
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 10239 documents.