Drugs

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.  

Guidances

 YearStatusTitleCenter
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) 

 

Page Last Updated: 04/17/2015
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