Skip to main content
U.S. flag

An official website of the United States government

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.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Q8, Q9, and Q10 Questions and Answers (R5)  Food and Drug Administration (FDA) Final
Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products: Draft Guidance  Food and Drug Administration (FDA) Proposed
Statistical Approaches to Establishing Bioequivalence  Food and Drug Administration (FDA) Final
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application  Food and Drug Administration (FDA) Final
Content of Human Factors Information in Medical Device Marketing Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Study Data Technical Conformance Guide - Technical Specifications Document  Food and Drug Administration (FDA) Final
Interim Final Rule with Comment Period: Medicaid Program; Community Engagement Requirement for Certain Individuals (CMS-2454-IFC)  Centers for Medicare & Medicaid Services (CMS) Final
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing  Food and Drug Administration (FDA) Proposed
Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
M15 General Principles for Model-Informed Drug Development  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4132 documents.