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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
Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals  Food and Drug Administration (FDA) Final
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Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Cross-Center Master Files: Where to Submit: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Monoclonal Antibodies: Streamlined Nonclinical Safety Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
E22 General Considerations for Patient Preference Studies  Food and Drug Administration (FDA) Proposed
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
This Guidance Portal contains 10239 documents.