Title of Collaborative Activity: |
Bioresource Development, Validation Tools, and Integrating HTS Technology Standards in CAM Product Use in Children |
Description of Collaborative Activity: |
Collaborative efforts between the FDA/CBER and the NIH/NCCAM for substantiating health benefit claims for probiotics under INDs were placed in the framework of U01 Cooperative Agreements that began in 2008. The successful evaluation of the initiative has recently developed into an invitation to develop a Memorandum of Understanding to promote resource sharing and exchange of research expertise; development of demonstration project(s); and the initiation of trans-agency research initiatives focused on the integration of advanced molecular technologies that lead to harmonization standards and improved diagnostics for safety and substantiation of the health benefits of probiotic interventions. In 2011, a collaboration with FDA/CFSAN was initiated to expand the validation tool. In 2012, a Materials Transfer Agreement [MTA] was approved and the FDA/CFSAN received the entire data collection to undergo testing employing their novel microarray multi-loci sequence testing system [MLST]. |
