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 "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.