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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
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
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
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
Development of Non-Opioid Analgesics for Acute Pain  Food and Drug Administration (FDA) Proposed
Guidance for Industry: Protein Efficiency Ratio (PER) Rat Bioassay Studies to Demonstrate that a New Infant Formula Supports the Quality Factor of Sufficient Biological Quality of Protein  Food and Drug Administration (FDA) Final
M14 General Principles on Planning, Designing, Analyzing, and Reporting of Non-interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines  Food and Drug Administration (FDA) Final
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions: Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Final
Expedited Programs for Regenerative Medicine Therapies for Serious Conditions: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Q3E Guideline for Extractables and Leachables  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 5699 documents.