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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
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
E2E Pharmacovigilance Planning  Food and Drug Administration (FDA) Final
E2F Development Safety Update Report  Food and Drug Administration (FDA) Final
E3 Structure and Content of Clinical Study Reports  Food and Drug Administration (FDA) Final
E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1)  Food and Drug Administration (FDA) Final
E4 Dose-Response Information to Support Drug Registration  Food and Drug Administration (FDA) Final
E5 Ethnic Factors in the Acceptability of Foreign Clinical Data  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4735 documents.