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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
Developing and Submitting Proposed Draft Guidance Relating to Patient Experience Data  Food and Drug Administration (FDA) Proposed
Therapy Services  Centers for Medicare & Medicaid Services (CMS) Final
TANF-ACF-PI-2018-02 (revises and supersedes TANF-ACF-PI 2005-03)  Administration for Children and Families (ACF) Final
Labeling of Red Blood Cell Units with Historical Antigen Typing Results: Guidance for Industry  Food and Drug Administration (FDA) Final
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry  Food and Drug Administration (FDA) Final
2019 Part B MAC Update  Centers for Medicare & Medicaid Services (CMS) Final
Manufacturing Site Change Supplements: Content and Submission: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Data Integrity and Compliance With Drug CGMP: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Interpretation of the “Deemed to be a License” Provision of the Biologics Price Competition and Innovation Act of 2009 : Guidance for Industry  Food and Drug Administration (FDA) Final
Biomarker Qualification: Evidentiary Framework: Draft Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5497 documents.