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U.S. Department of Health and Human Services

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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

 

 

IPRG Organization chart

 

Participants in the IPRG

Avigan, Mark I
Becker, Robert
Catalano, Jennifer
Chan, Maria M
Dragan, Yvonne
Dunham, Bernadette M
Frueh, Felix
Fuscoe, James
Galson, Steven
Goodman, Jesse
Goodsaid, Federico

Gutman, Steve
Hackett, Joe
Hewlett, Indira
Huang, Shiew Mei
Jacobson-Kram, David
Kodell, Ralph
Kozlowski, Steven
Leighton, John K
Lesko, Lawrence J
Lightfoote, Marilyn
Meyer, Robert J
Murphy, Shirley
ONeill, Robert T
Puri, Raj K.
Rudman, Allen
Schultz, Daniel
Slikker, William
Sundlof, Stephen F
Temple, Robert
Throckmorton, Douglas C
Tiwari, Jawahar
Vishnuvajjala, R. Lakshmi
Wang, Sue Jane
Woodcock, Janet