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
E19 OPTIMISATION OF SAFETY DATA COLLECTION  Food and Drug Administration (FDA) Proposed
E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports  Food and Drug Administration (FDA) Proposed
E6(R3) Good Clinical Practice (GCP)  Food and Drug Administration (FDA) Final
Early Alzheimer’s Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment  Food and Drug Administration (FDA) Final
Endogenous Cushing’s Syndrome: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Establishing Effectiveness and Safety for Hormonal Drug Products Intended to Prevent Pregnancy Guidance for Industry  Food and Drug Administration (FDA) Proposed
Estrogen and Estrogen/Progestin Drug Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms — Recommendations for Clinical Evaluation  Food and Drug Administration (FDA) Proposed
Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease, a Patient-Reported Outcome Instrument for the Measurement of Severity of Respiratory Symptoms in Stable Chronic Obstructive Pulmonary Disease: Qualification for Exploratory Use  Food and Drug Administration (FDA) Proposed
Evaluation of Therapeutic Equivalence  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.