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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
Development of Non-Opioid Analgesics for Chronic Pain  Food and Drug Administration (FDA) Proposed
Early Alzheimer’s Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Erosive Esophagitis: Developing Drugs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers Guidance for Industry  Food and Drug Administration (FDA) Proposed
Applications Covered by Section 505(b)(2)  Food and Drug Administration (FDA) Proposed
Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency Guidance for Submitting HCV Resistance Data -Attachment to Guidance  Food and Drug Administration (FDA) Proposed
Crohn’s Disease: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program  Food and Drug Administration (FDA) Proposed
Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4126 documents.