Title of Collaborative Activity: |
Bioresource Development, Validation Tools, and Integrating High-Throughput Screening Technology Standards in Complementary and Alternative Medicine (CAM) Product Use in Children |
Description of Collaborative Activity: |
Collaborative efforts between the Food and Drug Administration (FDA) and National Institutes of Health (NIH) for substantiating health benefit claims for probiotics under Investigational New Drug Applications (IND) 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 (MoU) 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 was initiated to expand the validation tool. In 2012, a Materials Transfer Agreement [MTA] was approved and the FDA received the entire data collection to undergo testing employing their novel microarray multi-loci sequence testing system [MLST]. |
