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HHS Guidance Submissions

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Title OpDiv/StaffDiv Guidance Status Issue Date
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Questions and Answers (R3) Guidance for Industry  Food and Drug Administration (FDA) Final
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
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) 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
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