Other FDA Resources Related to Pharmacogenomics

Back to Pharmacogenomics: Overview of the Genomics and Targeted Therapy Group



FDA Guidences Related to Pharmacogenomics

YearStatusGuidence Title
2016DraftUse of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (PDF, 499KB)
2016DraftUse of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases (PDF, 708 KB)
2016DraftPrinciples for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product (PDF, 1.1 MB)
2016FinalClinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF, 143.8 KB)
2015DraftE18 Guideline on Genomic Sampling and Management of Genomic Data (PDF, 170.5KB)
2014FinalQualification Process for Drug Development Tools (PDF, 498.8 KB)
2014FinalIn Vitro Companion Diagnostic Devices (PDF, 159.2 KB)
2014DraftFramework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (PDF, 312.5 KB)
2013FinalClinical Pharmacogenomics: Premarketing Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling (PDF, 130.6 KB)
2012DraftEnrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products (PDF, 996.7 KB)
2012DraftDrug Interaction Studies — Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations (PDF, 827 KB)
2011FinalE16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions (PDF, 708 KB)
2010DraftAdaptive Design Clinical Trials for Drugs and Biologics (PDF, 423.1 KB)
2008FinalE15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (PDF, 1.1 MB)
2005Final Pharmacogenomic Data Submissions (PDF, 306.9 KB)

*For a complete list of official FDA guidances, visit FDA guidance documents.

Additional FDA Resources Related to Pharmacogenomics


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