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Genomics
at FDA
Genomic Data Submission
Genomic Data Submissions
FDA recognizes that its pharmacogenomic data submission policies
must be consistent with the relevant codified regulatory submission
requirements for investigational and marketing application
submitters and holders. Although, at present, many
pharmacogenomic results are not well enough established
scientifically to be appropriate for regulatory decision making,
pharmacogenomic data submissions must comply with relevant codified
regulatory submission requirements for investigational and marketing
application submitters and holders. The guidance for industry "Pharmacogenomic
Data Submissions "
 and
the guidance attachment "Examples of Voluntary Submissions or Submissions
Required Under 21 CFR 312, 314, or 601"
clarify for sponsors FDA's current thinking
about when the regulations require pharmacogenomic data to be
submitted and when the submission of such data would be welcome on a
voluntary basis.
In particular, this new guidance provides
clarification on:
- What genomic data to
submit to the Agency and when
- What format to use for
the submissions
- How the data will be
used in regulatory decision making
The core of
the Guidance are three decision trees
that detail what genomic data needs to be submitted to an IND, NDA,
BLA or supplement and when.
The Guidance also
provides a new process by which genomic data can be submitted to the
Agency voluntarily (Voluntary
Genomic Data Submission (VGDS)). Voluntarily submitted data will
not be used for regulatory decision making.
FDA has created a
new procedure that prevents the review
of non-voluntary submissions from being compromised by the review of
information from voluntary submissions. A newly
formed Agency-wide review group, the
Interdisciplinary Pharmacogenomics Review Group (IPRG),
is responsible for the review of voluntary genomic data submission.
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Date created: March 22, 2005, updated October 31,
2005 |
