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Companion Diagnostics in Personalized Medicine and Cancer Therapy
Date:8/6/2014

/>Appendix 1: FDA Guidance for Industry: Pharmacogenomic Data Submissions 265
Appendix 1.1: Introduction 265
Appendix 1.2: Background 265
Appendix 1.3: Submission Policy 266
Appendix 1.3.1: General Principles 266
Appendix 1.3.2: Specific Uses of Pharmacogenomic Data in Drug Development and Labeling 268
Appendix 1.3.3: Benefits of Voluntary Submissions to Sponsors and FDA 269
Appendix 1.4: Submission of Pharmacogenomic Data 269
Appendix 1.4.1: Submission of Pharmacogenomic Data During the IND Phase 270
Appendix 1.4.2: Submission of Pharmacogenomic Data to a New NDA, BLA or Supplement 271
Appendix 1.4.3: Submission to a Previously Approved NDA or BLA 272
Appendix 1.4.4: Compliance with 21 CFR Part 58 272
Appendix 1.4.5: Submission of Voluntary Genomic Data from Application-Independent Research 272
Appendix 1.5: Format and Content of a VGDS 273
Appendix 1.6: Process for Submitting Pharmacogenomic Data 274
Appendix 1.7: Agency Review of VGDSs 274
Appendix 2: FDA Issues Draft Companion Diagnostic Guidance 276
Appendix 3: Histochemical Markers for Cancer 278
Appendix 4: E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions 279

Appendix 4.1: Introduction 279
Appendix 4.2: Background 279
Appendix 4.3: Scope 279
Appendix 4.4: General Principles 279
Appendix 4.5: Structure of Biomarker Qualification Submissions 280
Appendix 5: Selected Personalized Medicine Drugs, Treatments and Diagnostics as of June 2014 287
Glossary 292


INDEX OF FIGURES

Figure 2.1: Strategic and Tactical Considerations for Co-Development of Companion Diagnostics 24
Figure 2.2: Global Market for Companion Diagnostics, 2012-2019 25
Figure 2.3: Number of Companion Diagnostic Agreements, 2000-2013 26
Figure 2.4: Surface Binding Produces Phase Shifts that Increases the Diffraction Signal Intensity 36'/>"/>

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