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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
E15 Pharmacogenomics Definitions and Sample Coding  Food and Drug Administration (FDA) Final
E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions  Food and Drug Administration (FDA) Final
E17 General Principles for Planning and Design of Multi-Regional Clinical Trials  Food and Drug Administration (FDA) Final
E18 Genomic Sampling and Management of Genomic Data Guidance for Industry  Food and Drug Administration (FDA) Final
E19 A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-Approval or Post-Approval Clinical Trials  Food and Drug Administration (FDA) Final
E1A The Extent of Population Exposure to Assess Clinical Safety: For Drugs Intended for Long-term Treatment of Non-Life-Threatening Conditions  Food and Drug Administration (FDA) Final
E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting  Food and Drug Administration (FDA) Final
E2B(M) Questions and Answers  Food and Drug Administration (FDA) Final
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility  Food and Drug Administration (FDA) Final
E2B(R3) The Electronic Transmission of Individual Case Safety Reports Implementation Guide —Appendix to the Implementation Guide — Backwards and Forwards Compatibility  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.