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
Drug-Induced Liver Injury: Premarketing Clinical Evaluation  Food and Drug Administration (FDA) Final
Drugs for the Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients 1 Month of Age and Older  Food and Drug Administration (FDA) Final
DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry  Food and Drug Administration (FDA) Final
DSCSA Implementation: Product Tracing Requirements — Compliance Policy  Food and Drug Administration (FDA) Final
DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry  Food and Drug Administration (FDA) Final
Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Final
E10 Choice of Control Group and Related Issues in Clinical Trials  Food and Drug Administration (FDA) Final
E11 Clinical Investigation of Medicinal Products in the Pediatric Population  Food and Drug Administration (FDA) Final
E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population  Food and Drug Administration (FDA) Final
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.