NCL Partnerships - FDAU.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:
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A Service of the National Cancer Institute |