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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
Rescission of Guidance on “Fast Track” Federal Review Process for Section 1115 Demonstration Extensions  Centers for Medicare & Medicaid Services (CMS) Final
Submitting Next-Generation Sequencing Data to the Division of Antiviral Products  Food and Drug Administration (FDA) Final
Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials  Food and Drug Administration (FDA) Proposed
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
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
Q8, Q9, and Q10 Questions and Answers (R5)  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4042 documents.