Interdisciplinary Pharmacogenomics Review Group (IPRG)

The mission of the Interdisciplinary Pharmacogenomics Review Group (IPRG) is to establish a scientific and regulatory framework for reviewing genomic data. The IPRG is an Agency-wide review group, whose members include individuals from CDER, CBER, CDRH, NCTR, OCP and CVM.

The IPRG is the primary review body for Voluntary Exploratory Data Submissions (VXDS) [formerly Voluntary Genomic Data Submissions (VGDS)]. Upon request, the IPRG also consults with FDA review staff on the review of required submissions, e.g., IND, NDA, BLA or IDE, containing genomic data.

Further information on the function and responsibilities of this group can be found in the document “Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG),” MaPP 4180.2 (PDF - 149KB).

Organization of the IPRG

Participants in the IPRG