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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New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4): Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed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
Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations: Draft Guidance for Industry  Food and Drug Administration (FDA) Proposed
CVM GFI #299 -Dual Labeling for Fully Approved and Conditionally Approved New Animal Drugs with a New World Screwworm-Related Indication: Guidance for Industry  Food and Drug Administration (FDA) Final
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
E20 Adaptive Designs for Clinical Trials  Food and Drug Administration (FDA) Proposed
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 10239 documents.