A public workshop that will aim to facilitate the establishment of protocols for ensuring the safety and quality of next-generation sequencing (NGS)-related-information without sacrificing scientific merit or interfering with innovative processes. This will be done by engaging NGS stakeholders in a forum to discuss the current use of NGS technology and the development of standards for related information. In addition, it will highlight FDA proposed guidelines for addressing NGS data storage, archival and quality control steps needed for computational biology protocols with relation to FDA relevant regulatory science.
When & Where
FDA Genomic Working Group
A group of representative with expertise in high throughput sequencing technology application and bioinformatics relevance whose goal is to develop the IT infrastructure, material and data standards, and analytic approaches that are required to support use and application of this exciting new technology in order to solve scientific questions and support regulatory decision-making. As well as to ensure that the resources and expertise required are identified, implemented, and developed in a coordinated fashion, both internally, and where feasible, with other government agencies.