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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
E22 General Considerations for Patient Preference Studies  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Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Cross-Center Master Files: Where to Submit: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q3E Guideline for Extractables and Leachables  Food and Drug Administration (FDA) Proposed
Q3E Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs  Food and Drug Administration (FDA) Proposed
Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs: Guidance for Industry  Food and Drug Administration (FDA) Final
Computer Software Assurance for Production and Quality Management System Software: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 8098 documents.