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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
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
E2BM Data Elements for Transmission Of Individual Case Safety Reports  Food and Drug Administration (FDA) Final
E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER)  Food and Drug Administration (FDA) Final
E2C(R2) Periodic Benefit-Risk Evaluation Report – Questions and Answers  Food and Drug Administration (FDA) Final
E2D Postapproval Safety Data Management: Definitions and Standards for Expedited Reporting  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.