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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
Early Alzheimer’s Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
Pharmacokinetics in Patients with Impaired Renal Function — Study Design, Data Analysis, and Impact on Dosing  Food and Drug Administration (FDA) Final
Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Initial Core Set Mandatory Reporting Guidance for the Health Home Core Quality Measure Sets and Federal Fiscal Year 2025 Updates to the Health Home Core Quality Measure Sets (SMD 24-002)  Centers for Medicare & Medicaid Services (CMS) Final
Conducting Medicaid and CHIP Renewals During the Unwinding Period and Beyond: Essential Reminders  Centers for Medicare & Medicaid Services (CMS) Final
Change Healthcare Cybersecurity Incident – CMS Response and State Flexibilities  Centers for Medicare & Medicaid Services (CMS) Final
Illustrative Examples of Processes Not Permitted Under Medicaid and CHIP Renewal Requirements  Centers for Medicare & Medicaid Services (CMS) Final
Controlled Correspondence Related to Generic Drug Development  Food and Drug Administration (FDA) Final
CVM GFI #285 - Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4024 documents.