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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
Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards  Food and Drug Administration (FDA) Proposed
Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
PI-24-04 - Instructions for State Courts on Applying for State Court Improvement Program (CIP) Funds for Fiscal Year (FY) 2025  Administration for Children and Families (ACF) Final
Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes - Dietary Supplements  Food and Drug Administration (FDA) Final
Q2(R2) Validation of Analytical Procedures  Food and Drug Administration (FDA) Final
Q14 Analytical Procedure Development  Food and Drug Administration (FDA) Final
Strategies to Improve Delivery of Tobacco Cessation Services  Centers for Medicare & Medicaid Services (CMS) Final
Guidance for the Tribal Child Support Program Start-Up Application Process  Administration for Children and Families (ACF) Final
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
This Guidance Portal contains 4040 documents.