NCL Partnerships - FDA

U.S. Food and Drug Administration (FDA)

FDA (http://www.fda.gov/) has developed a strong and standardized model for evaluating diagnostics, has a new integrated regulatory program for regulation of diagnostic devices (Office of in vitro Diagnostic Device Evaluation and Safety), and has begun to explore methods for evaluating multiplex technologies and for better incorporating new diagnostics into drug development when appropriate. While the agency has limited experience with nanotechnology, it has great interest in developing mechanisms for facilitated review and for ensuring rapid but science-based decision-making in regulation of this new technology.

Examples of FDA’s ongoing projects with NCI include:

• FDA/NCI clinical proteomics program – collaboration on nanoparticle harvesting agents for biomarker discovery
• FDA/NCI clinical proteomics program – development of new nanomaterials for protein microarray development
• FDA/NCI clinical proteomics program – nanotoxicology studies using phosphoproteomic signature analysis/signal pathway protein microarrays
• National Center for Toxicological Research (NCTR) – evaluation of exposure to nanotechnology using gene expression microarrays