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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
Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies: Guidance for Industry  Food and Drug Administration (FDA) Final
Wholesale Distributor Verification Requirement for Saleable Returned Drug Product—Compliance Policy Guidance for Industry: Guidance for Industry  Food and Drug Administration (FDA) Final
“Lookback” for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV: Guidance for Industry  Food and Drug Administration (FDA) Final
Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Applications for Premarket Review of New Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessment of Pressor Effects of Drugs Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4741 documents.