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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
Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Using a Centralized IRB Review Process in Multicenter Clinical Trials: Guidance for Industry  Food and Drug Administration (FDA) Final
Validation of Procedures for Processing of Human Tissues Intended for Transplantation: Guidance for Industry  Food and Drug Administration (FDA) Final
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs: Guidance for Industry  Food and Drug Administration (FDA) Final
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Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Applications for Premarket Review of New Tobacco Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 4735 documents.