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
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
E15 Pharmacogenomics Definitions and Sample Coding  Food and Drug Administration (FDA) Final
E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions  Food and Drug Administration (FDA) Final
E17 General Principles for Planning and Design of Multi-Regional Clinical Trials  Food and Drug Administration (FDA) Final
E18 Genomic Sampling and Management of Genomic Data Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.