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
Establishing Effectiveness for Drugs Intended to Treat Male Hypogonadotropic Hypogonadism Attributed to Nonstructural Disorders Guidance for Industry  Food and Drug Administration (FDA) Final
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers  Food and Drug Administration (FDA) Final
Evaluating Drug Effects on the Ability to Operate a Motor Vehicle  Food and Drug Administration (FDA) Final
Evaluating the Risks of Drug Exposure in Human Pregnancies  Food and Drug Administration (FDA) Final
Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act  Food and Drug Administration (FDA) Final
Evaluation of Internal Standard Responses During Chromatographic Bioanalysis: Questions and Answers  Food and Drug Administration (FDA) Final
Evaluation of Sex-Specific Data in Medical Device Clinical Studies - Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.