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Other FDA Resources Related to Pharmacogenomics

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

FDA Guidances Related to Pharmacogenomics

Year Status Guidence Title
2019 Final Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products
2018 Final Considerations for Design, Development, and Analytical Validation of Next Generation Sequencing (NGS) – Based In Vitro Diagnostics (IVDs) Intended to Aid in the Diagnosis of Suspected Germline Diseases Guidance for Stakeholders and Food and Drug Administration Staff
2018 Final E18 Genomic Sampling and Management of Genomic Data
2018 Draft Expansion Cohorts: Use in First-In-Human Clinical Trials to Expedite Development of Oncology Drugs and Biologics
2018 Draft Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics
2018 Draft Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics
2018 Draft Rare Diseases: Early Drug Development and the Role of Pre-IND Meetings
2018 Draft Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products
2018 Draft Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination
2018 Draft Biomarker Qualification: Evidentiary Framework
2018 Final Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease 
2018 Draft Adaptive Design Clinical Trials of Drugs and Biologics
2016 Draft Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product (PDF, 1.1 MB)
2016 Final Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (PDF, 143.8 KB)
2015 Draft E18 Guideline on Genomic Sampling and Management of Genomic Data (PDF, 170.5KB)
2014 Final Qualification Process for Drug Development Tools (PDF, 498.8 KB)
2014 Final In Vitro Companion Diagnostic Devices (PDF, 159.2 KB)
2014 Draft Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) (PDF, 312.5 KB)
2013 Final Clinical Pharmacogenomics: Premarketing Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling (PDF, 130.6 KB)
2011 Final E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions (PDF, 708 KB)
2008 Final E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories (PDF, 1.1 MB)
2007 Final Pharmacogenetic Tests and Genetic Tests for Heritable Markers
2005 Final  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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