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
Conducting Remote Regulatory Assessments Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Current Good Manufacturing Practice for Medical Gases: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Non-Opioid Analgesics for Acute Pain; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Enforcement Policy for Certain Marketed Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.