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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
Mpox: Development of Drugs and Biological Products; Guidance for Industry  Food and Drug Administration (FDA) Proposed
Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Nonalcoholic Steatohepatitis with Compensated Cirrhosis: Developing Drugs for Treatment Guidance for Industry  Food and Drug Administration (FDA) Proposed
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment  Food and Drug Administration (FDA) Proposed
Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics  Food and Drug Administration (FDA) Proposed
Nonproprietary Naming of Biological Products: Update Guidance for Industry  Food and Drug Administration (FDA) Proposed
Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act  Food and Drug Administration (FDA) Proposed
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework Guidance for Industry  Food and Drug Administration (FDA) Proposed
Osteoarthritis: Structural Endpoints for the Development of Drugs  Food and Drug Administration (FDA) Proposed
Over-the-Counter Monograph Order Requests: Format and Content  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.