Genomics
at FDA
Voluntary Exploratory Data Submission (VXDS)
[formerly Voluntary Genomic Data Submission (VGDS)]
About Voluntary Exploratory Data
Submissions
Voluntary Exploratory
Data Submissions (VXDSs) are a novel way to share information with
the FDA. At the current time, most pharmacogenomic data are of an
exploratory or research nature and FDA regulations do not require
that these data be submitted to an IND, or that complete reports be
submitted to an NDA or BLA. However, voluntary submissions can
benefit both the industry and the FDA in a general way by providing
a means for sponsors to ensure that regulatory scientists are
familiar with and prepared to appropriately evaluate future genomic
submissions.
FDA and industry
scientists alike would benefit from an enhanced understanding of
relevant scientific issues, such as the following:
- The types of genetic loci or gene expression profiles being
explored by the pharmaceutical industry for pharmacogenomic
testing
- The test systems and techniques being employed
- The problems encountered in applying pharmacogenomic tests to
drug development
- The ability to transmit, store, and process large amounts of
complex pharmacogenomic data streams with retention of fidelity
- The scientific rationale for standardizing naming and
characterization of the genes used on different genomic analysis
platforms and for developing bioinformatics software programs used
to evaluate pharmacogenomic data
A greater
understanding of the issues surrounding the use of pharmacogenomic
data may prevent delays in reviews of future submissions where
genomics are an integral part of specific studies in a drug
development program.
Therefore, the FDA
is requesting that sponsors conducting such programs consider
providing pharmacogenomic data to the Agency voluntarily, when such
data are not otherwise required under the regulations. To
facilitate voluntary exploratory data submissions (VXDSs), FDA has
established a cross-center Interdisciplinary Pharmacogenomic Review Group (IPRG)
to review VXDSs, to work on policy development, and, upon request,
to advise review divisions on interpretation and evaluation of
pharmacogenomic data.
For sponsors,
voluntary submission of genomic data offers a number of specific
potential benefits:
- It creates an opportunity for early informal meetings
with FDA pharmacogenomics experts
- It offers flexibility in review and meeting process
- Sponsors receive and benefit from informal peer-review
feedback on pharmacogenomic issues and/or questions
- Sponsors gain insight into current FDA thinking about
pharmacogenomics that may assist in reaching important strategic
decisions
- It offers time- and cost-savings by familiarizing both parties
early with novel pharmacogenomic approaches avoiding future delays
in review
- It provides an opportunity for sponsors to impact FDA’s
thinking and help build consensus around future pharmacogenomic
standards, policies and guidances
This process for voluntarily submitting
genomic data to the FDA is further detailed in the document
“Processing and Reviewing Voluntary Genomic
Data Submissions (VGDSs),” MaPP 4180.3.
VGDS Process Flow
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Date created: March 22, 2005; updated January 21, 2009 |