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
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Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Final
Importation of Certain FDA- Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry  Food and Drug Administration (FDA) Final
Wilson-Fish TANF Coordination Program Grantees (PDF)  Administration for Children and Families (ACF) Final
Guidance for Industry: The Declaration of Allulose and Calories from Allulose on Nutrition and Supplement Facts Labels  Food and Drug Administration (FDA) Final
Guidance for Industry: U.S. Agent Voluntary Identification System (VIS) for Food Facility Registration  Food and Drug Administration (FDA) Final
Testing for Biotin Interference in In Vitro Diagnostic Devices: Guidance for Industry  Food and Drug Administration (FDA) Final
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies  Food and Drug Administration (FDA) Final
MLN Product (Revised) Repairs & Replacements of Off-the-Shelf Back & Knee Braces (MLN905283)  Centers for Medicare & Medicaid Services (CMS) Final
MLN Product (Revised) DMEPOS Competitive Bidding Program: Traveling Patients (MLN904484)  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 4742 documents.