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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
Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Submission of Warning Plans for Cigarettes and Smokeless Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Tissue Agnostic Drug Development in Oncology: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Early Development Considerations for Innovative Combination Products: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Application of Human Factors Engineering Principles for Combination Products: Questions and Answers: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
The Use of Clinical Holds Following Clinical Investigator Misconduct: Guidance for Industry and Clinical Investigators  Food and Drug Administration (FDA) Final
Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products: Guidance for Industry and FDA  Food and Drug Administration (FDA) Final
Investigational Device Exemption (IDE) Guidance for Retinal Prostheses: Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Collection of Platelets by Automated Methods: Guidance for Industry and FDA Review Staff  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.