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
CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication: Guidance for Industry  Food and Drug Administration (FDA) Final
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry  Food and Drug Administration (FDA) Final
Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals  Food and Drug Administration (FDA) Final
Medical Devices with Indications Associated with Weight Loss - Premarket Considerations: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Bioanalytical Method Validation for Biomarkers  Food and Drug Administration (FDA) Final
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application: Guidance for Industry  Food and Drug Administration (FDA) Final
Submitting Continuous Glucose Monitoring Data in Clinical Trials  Food and Drug Administration (FDA) Final
Enforcement Priorities for Certain New Tobacco Products Marketed Without Premarket Authorization  Food and Drug Administration (FDA) Final
Medicaid Managed Care Payments and Emergency Medical Condition Coverage for Aliens Ineligible for Full Medicaid Benefits  Centers for Medicare & Medicaid Services (CMS) Final
This Guidance Portal contains 4128 documents.