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U.S. Department of Health and Human Services

Drugs

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Genomics: Frequently Asked Questions

 

        

Voluntary Exploratory Data Submissions (VXDS) Program

The following frequently asked questions refer to the Voluntary Exploratory Data Submissions (VXDS and X=exploratory) program (formerly the Voluntary Genomic Data Submission (VGDS) program).

  1. What are the steps to submit VXDSs?
    • The initial step is to contact the Office of Clinical Pharmacology Associate Director for Genomics (fdagenomics@fda.hhs.gov) to discuss the scope of the proposed VXDS.

    • If appropriate, the VXDS documents can then be submitted, with an approximate meeting date with FDA scientists to occur 6-8 weeks later if requested. 

  2. Who participates in the review of VXDSs? 

    Members from a pool of scientific experts at FDA participate. Members form a specific interdisciplinary scientific exchange group (ISEG). The exact membership of an ISEG for a given VXDS depends on the scope of the submission (e.g., clinical, non-clinical, particular therapeutic area). The Office of Clinical Pharmacology Associate Director for Genomics (or his designee) serves as the chair of the ISEG. 

  3. How is the scientific nature of a VXDS discussion structured?

    The ISEG engages submitters of VXDSs in a scientific discussion. This can occur through flexible mechanisms such as teleconferences, web-based interactions, or face-to-face meetings. 

  4. How will confidentiality of the VXDS be ensured by the Agency?

    All VXDSs are protected from disclosure in a manner consistent with our policies for disclosure of other data submitted to INDs, new drug applications (NDAs), and biologic license applications (BLAs). All VXDS data will be routed directly to the ISEG chair and stored on a secure server at FDA's National Center for Toxicology Research (NCTR).

  5. How will the VXDS data be distributed within the Agency?

    All VXDS data are handled through the VXDS program administration. Data will be distributed only within the ISEG, unless there is prior agreement with the VXDS submitter to share the data more broadly.

  6. How will VXDS data be stored within the Agency?

    All VXDS data will be stored on a separate secure server at NCTR. It will not be distributed outside of the bounds of the VXDS program without the prior agreement of the submitter.

  7. What are some of the incentives to submit VXDS?
    • Provides opportunity to have informal meeting with FDA scientists with diverse expertise

    • Receive and benefit from informal peer-review feedback on a range of issues including (but not limited to) those surrounding exploratory data

    • Gain insight into current FDA thinking about exploratory data that may assist in strategic decisions

    • Familiarize FDA with novel findings, innovative methodologies, and emerging technologies that may inform future FDA standards and policies

  8. Who can submit VXDSs? 

    FDA encourages any interested parties to contact the VXDS program to determine whether VXDS is the best mechanism for scientific exchange. Submitters can be pharmaceutical or diagnostic firms, academic researchers, consortia, or others.

  9. We have genomic data related to a previous clinical submission that was not approved. Can we submit it as a VXDS?

    Yes.


Pharmacogenomics Biomarkers in FDA-Approved Drug Labels

  1. How many drugs have pharmacogenomic information in their labels?

    There are numerous drugs or drug pairs that contain pharmacogenomic information in the label. Many of these labels, along with information on the specific biomarker, therapeutic area, and relevant section of the label can be found in the Table for at Pharmacogenomic Biomarkers in Drug Labels.

  2. Are there FDA-cleared or approved pharmacogenomic tests for biomarkers that appear in FDA-approved drug labels?

    Some FDA-cleared or approved tests do exist. A searchable database of CDRH-cleared or approved tests can be found on the Medical Device Databases web page. A list of nucleic acid based tests and a list of in vitro companion diagnostics devices are also available.