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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 Clinical Investigation Exclusivity (3-Year Exclusivity) for Drug Products: Questions and Answers  Food and Drug Administration (FDA) Proposed
Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause  Food and Drug Administration (FDA) Proposed
Questions and Answers About Requirements for Additional Traceability Records for Certain Foods: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Defining Durations of Use for Certain Medically Important Antimicrobial Drugs for Food-Producing Animals  Food and Drug Administration (FDA) Final
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
Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
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Cross-Center Master Files: Where to Submit: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
This Guidance Portal contains 11354 documents.