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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Enforcement Policy for Certain Marketed Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Bacillus Calmette-Guérin-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act (Revision 1): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Collecting and Providing 702(b) Portions of FDA Official Samples: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5495 documents.