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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
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
CVM GFI #91 (VICH GL8 (R)) Stability Testing for Medicated Premix (or Type A Medicated Article) (Revision 1)  Food and Drug Administration (FDA) Proposed
Medical Gases — Current Good Manufacturing Practice: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry  Food and Drug Administration (FDA) Final
New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
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
This Guidance Portal contains 11397 documents.