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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
Technical Specifications for Submitting Clinical Trial Data Sets for Response Assessments for Treatments of Acute Leukemias: Guidance for Industry Technical Specifications Document  Food and Drug Administration (FDA) Final
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
Menstrual Products - Performance Testing and Labeling Recommendations: Draft Guidance for Industry and Food and Drug Administration Staff  Food and Drug Administration (FDA) Proposed
Proposed Rule: Medicaid Managed Care State Directed Payments and Medicaid Fee-For-Service Targeted Medicaid Practitioner Payments (CMS-2449-P)  Centers for Medicare & Medicaid Services (CMS) Proposed
Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework  Food and Drug Administration (FDA) Proposed
Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Postapproval Pregnancy Safety Studies  Food and Drug Administration (FDA) Final
Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry  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
This Guidance Portal contains 5699 documents.