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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
Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs  Food and Drug Administration (FDA) Proposed
Q3E Guideline for Extractables and Leachables  Food and Drug Administration (FDA) Proposed
Cross-Center Master Files: Where to Submit: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry  Food and Drug Administration (FDA) Final
Postapproval Pregnancy Safety Studies  Food and Drug Administration (FDA) Final
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework  Food and Drug Administration (FDA) Proposed
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 10239 documents.