Description of Collaborative Activity: |
Recent advances have indicated that ribonucleic acids (RNAs) can play a role in a variety of complex cellular functions, including newly discovered mechanisms of cell-to-cell communication. RNA can be exported from cells in extracellular vesicles or bound to lipids or proteins, to circulate through the body and affect cells at a distance. However, the actual impact of the extracellular RNAs, or exRNAs, is currently unknown. National Institutes of Health (NIH) and Food and Drug Administration (FDA) have coordinated efforts on the preclinical and clinical use of exRNAs to address human health and disease. To date, several PIs have had pre-pre-IND meetings with FDA-Center for Biologics Evaluation and Research (CBER). They have been provided information necessary to submit applications, for example, a biomarkers device. |
