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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.

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HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Enforcement Policy for Required Warnings for Cigarette Packages and Advertisements  Food and Drug Administration (FDA) Final
Enforcement Policy on Marketing OTC Combination Products (CPG 7132b.16).  Food and Drug Administration (FDA) Final
Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act--Compliance Policies  Food and Drug Administration (FDA) Final
Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity  Food and Drug Administration (FDA) Final
Eosinophilic Esophagitis: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Final
Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Guidance for Industry  Food and Drug Administration (FDA) Final
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
This Guidance Portal contains 4741 documents.