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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
FDA Animal Products Database Data Entry Form  Food and Drug Administration (FDA) Final
Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application  Food and Drug Administration (FDA) Final
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Antibodies to Borrelia burgdorferi - Guidance for Industry and FDA Staff  Food and Drug Administration (FDA) Final
Good Laboratory Practice Regulations Questions and Answers  Food and Drug Administration (FDA) Final
Improving Teacher-Child Interactions: Using the CLASS in Head Start Preschool Programs  Administration for Children and Families (ACF) Final
E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility  Food and Drug Administration (FDA) Final
Exemption and Exclusion From Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency Guidance for Industry  Food and Drug Administration (FDA) Final
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices  Food and Drug Administration (FDA) Final
Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff  Food and Drug Administration (FDA) Final
Fees-Exceed-the-Costs Waivers Under the Prescription Drug User Fee Act  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.