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
Guidance for Industry: Suicidal Ideation and Behavior: Prospective Assessment of Occurrence in Clinical Trials  Food and Drug Administration (FDA) Proposed
General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products  Food and Drug Administration (FDA) Proposed
Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information  Food and Drug Administration (FDA) Proposed
Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention  Food and Drug Administration (FDA) Proposed
Gluten in Drug Products and Associated Labeling Recommendations; Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment  Food and Drug Administration (FDA) Proposed
Guidance for Industry 180-Day Exclusivity: Questions and Answers  Food and Drug Administration (FDA) Proposed
Harmonizing Compendial Standards With Drug Application Approval Using the USP Pending Monograph Process Guidance for Industry  Food and Drug Administration (FDA) Proposed
Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry  Food and Drug Administration (FDA) Proposed
Helicobacter pylori-Associated Duodenal Ulcer Disease in Adults: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.