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
Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA  Food and Drug Administration (FDA) Final
Using the Inactive Ingredient Database Guidance for Industry  Food and Drug Administration (FDA) Proposed
Draft Guidance for Industry: Application of the “Solely Engaged” Exemptions in Parts 117 and 507  Food and Drug Administration (FDA) Proposed
Long Term Follow-up After Administration of Human Gene Therapy Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for the Development of Dried Plasma Products Intended for Transfusion: Guidance for Industry  Food and Drug Administration (FDA) Final
Manufacturers/Assemblers of Diagnostic X-ray Systems: Enforcement Policy for Positive-Beam Limitation (PBL) Requirements in 21 CFR 1020.31(g) :  Food and Drug Administration (FDA) Final
Validation and Verification of Analytical Testing Methods Used for Tobacco Products  Food and Drug Administration (FDA) Final
Use of Data Monitoring Committees in Clinical Trials  Food and Drug Administration (FDA) Proposed
Upper Facial Lines: Developing Botulinum Toxin Drug Products  Food and Drug Administration (FDA) Proposed
Use of a Drug Master File for Shared System REMS Submissions Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.