How will confidentiality of the VXDS be ensured by the Agency?
All VXDS data will be protected from disclosure to the extent allowed by existing laws and regulations, and consistent with our policies for disclosure of other data submitted to INDs, new drug applications (NDAs), and biologic license applications (BLAs). Data that are submitted to existing INDs, NDAs, or BLAs will receive the number of their existing application. VXDS data that are not part of an existing submission will receive a new IND number. All VXDS data will be routed directly to the IPRG, not the review division, and will stored on a secured, separate server.
