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U.S. Department of Health and Human Services


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Genomics Guidances, Concept Papers, and MaPPs

The following listing includes FDA guidances, concept papers and operating procedures that deal with the development and application of genomic technologies in therapeutic and/or device development.  


1997FinalDrug Metabolism/ Drug Interaction Studies in the Drug Development Process: In Vitro (PDF - 109KB)CDER, CBER
2005FinalClass II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems (PDF - 60KB) CDRH
2005FinalClass II Special Controls Guidance Document: CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) Gene Mutation Detection Systems  [PDF version - 69KB]CDRH
2005FinalClass II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System  [PDF version - 72KB]CDRH
2005FinalPharmacogenomic Data Submission (PDF - 96KB)CDER, CBER, CDRH
2006DraftDrug Interaction Studies - Study Design, Data Analysis, and implications for Dosing and Labeling (PDF - 253KB)CDER, CBER
2007DraftPharmacogenomic Data Submission - Companion Guidance (PDF -211KB)CDER, NCTR, CBER, CDRH
2007FinalClass II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer PrognosisCDRH
2007FinalPharmacogenomic Tests and Genetic Tests for Heritable Markers (PDF - 66KB)CDRH, CDER, CBER
2007DraftIn Vitro Diagnostic Multivariate Index Assays (PDF - 72KB)CDRH, CBER
2007FinalCommercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions (PDF - 139KB)CDRH, CBER
2009 DraftClinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products - Content and Format (PDF - 144KB) CDER, CBER 
2009 Final Drug-Induced Liver Injury: Premarketing Clinical Evaluation (PDF - 206KB) CDER, CBER  
2010Draft Adaptive Design Clinical Trials for Drugs and Biologics (PDF - 436KB) CDER, CBER 
2010Draft Qualification Process for Drug Development Tools (PDF -190KB) CDER 
2010DraftChronic Hepatitis C Virus Infection: Developing Direct-Acting Agents for Treatment (PDF - 306KB)CDER
2011DraftUse of Histology in Biomarker Qualification Studies (PDF -298KB)CDER
2011DraftIn Vitro Companion Diagnostic Devices (PDF - 134KB)CDRH
2012DraftEnrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (PDF - 997KB)CDER, CBER, CDRH
2013FinalClinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies (PDF - 531KB)CDER, CBER, CDRH

Concept Papers

 YearStatusTitle                       Center
2005Draft Drug-Diagnostic Co-Development Concept Paper (PDF - 479KB)                 FDA                    

Manual of Policies and Procedures (MAPPS)

2005 Final Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG) (PDF - 149KB)CDER
2005FinalProcessing and Reviewng Voluntary Genomic Data Submissions (VDGSs) (PDF - 146KB)CDER
2010FinalAn Integrated Genomics, Pharmacometrics, and Clinical Pharmacology Review Process (PDF – 144KB)CDER

Other Regulatory Agency Documents

2007FinalGuiding Principles: Processing Joint Food and Drug Administration and European Medicines Agency Voluntary Genomic Data Submissions within the Framework of the Confidentiality Agreement (PDF - 180KB) disclaimer icon FDA, EMA, EC
2008FinalE15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (PDF - 90KB)CDER, CBER, ICH
2010FinalE16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions (PDF - 150KB) disclaimer icon CDER, CBER, ICH