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
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
General Considerations for the Use of New Approach Methodologies in Drug Development  Food and Drug Administration (FDA) Proposed
Bioanalytical Method Validation for Biomarkers  Food and Drug Administration (FDA) Final
Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing  Food and Drug Administration (FDA) Proposed
Establishing Impurity Specifications for Antibiotics  Food and Drug Administration (FDA) Proposed
Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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 4050 documents.