Voluntary Exploratory Data Submissions (VXDSs) are a novel way to share information with the FDA. The VXDS program is a non-regulatory, flexible mechanism for scientific exchange between FDA and external scientists (e.g., industry scientists, academic researchers). While the VXDS program originated and is operated out of Center for Drug Evaluation and Research (CDER), scientists from other FDA Centers are included in Interdisciplinary Scientific Exchange Groups (ISEGs). Unique ISEGs may be formed for each VXDS to allow for exchange with appropriate content experts.
FDA and submitters of VXDSs alike would benefit from an enhanced understanding of relevant scientific issues of potential relevance to public health or therapeutic product development. The scope of VXDS meetings includes (but is not limited to) scientific discussions of:
- Complex diseases biology
- Determinants of drug response
- Drug discovery and development
- Innovations in trial designs and methodology
- Emerging technology
A greater understanding of the state of the art, issues, and challenges in the above areas may ultimately enhance therapeutic product development and/or advance regulatory science and policy.
Submitters of VXDSs benefit in the following ways:
- Opportunity for flexible, scientific, non-regulatory meetings with FDA experts
- Opportunity to gain insight into current FDA thinking about exploratory data that may assist in reaching important strategic decisions
- For drug developers, potential time-savings by familiarizing FDA early with novel exploratory data prior to regulatory submission (e.g., NDA or BLA)
- Opportunity to bring to FDA important issues that may inform future standards, policies, and guidances
For more information, contact Issam.Zineh@fda.hhs.gov