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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
Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics: Guidance for Industry  Food and Drug Administration (FDA) Final
Completeness Assessments for Type II API DMFs Under GDUFA Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance Policy for Certain Labeling and Warning Statement Requirements for Cigars and Pipe Tobacco: Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance Policy for Required Warning Statements on Small-Packaged Cigars: Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements: Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements: Guidance for Industry  Food and Drug Administration (FDA) Final
Compliance with Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco To Protect Children and Adolescents: Guidance for Industry  Food and Drug Administration (FDA) Final
Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment: Guidance for Industry  Food and Drug Administration (FDA) Final
Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 5495 documents.