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Genomics
at FDA
Interdisciplinary Pharmacogenomics Review Group (IPRG)
About the 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
Organization of the IPRG
Participants in 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
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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 |
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Date created: March 22, 2005, updated October 25,
2005 |
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