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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
Interpreting Sameness of Gene Therapy Products Under the Orphan Drug Regulations: 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
Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision: 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
Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects: Guidance for Industry  Food and Drug Administration (FDA) Final
IRB Review of Stand-Alone HIPAA Authorizations Under FDA Regulations: Guidance for Industry  Food and Drug Administration (FDA) Final
Labeling of Red Blood Cell Units with Historical Antigen Typing Results: Guidance for Industry  Food and Drug Administration (FDA) Final
Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms: Guidance for Industry  Food and Drug Administration (FDA) Final
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During COVID-19 Public Health Emergency: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4024 documents.