Overview of the Genomics Group

The Genomics Group, in FDA's Office of Clinical Pharmacology, works to advance the application of Genomics in the discovery, development, regulation, and use of medications.  

Vision: Advance the application of Genomics for the benefit of patients and society.  

Mission: Recognition of genomics as an integral discipline in the discovery, development, regulation and rational use of medications (DDRU) (graphic)
 

Discovery & Development
Identify and/or provide scientific and regulatory input on the use of biomarkers for safety and effectiveness.

• VXDS - Promote and evaluate the science behind voluntary exploratory biomarker data submissions.

• EOP2a – Maximize the impact of genomics in Phase 3 studies through active and routine participation of EOP2a.

Regulatory Review 
Advance FDA regulatory processes by providing expertise in translational sciences.

• Drugs & Biologics Review -  Impact regulatory review of drugs and  biologics by providing expertise in genomics and other translational sciences.

• Device Review - Impact regulatory review of diagnostics by providing expertise in genomics and other translational sciences.

•  BQP - Facilitate/enhance/assist identification and qualification of biomarkers to be used in drug/diagnostic development and regulatory review. 

Utilization
Influence the ongoing use of genomic data in marketed drugs to maximize benefit to risk ratio.

• Relabeling - Update drug product labels to incorporate relevant genomic information.

• Post Market Surveillance - Improve the safety and efficacy profile for approved drugs and biologics in sub-populations.

• Research - Perform high quality translational research throughout product life cycle.

• Outreach & Communication

• Education & Training

• Policy Analysis/Development

• Knowledge Management