Safety of Nanotechnology Cancer Treatment

As with any emerging technology, ensuring the safety of nanotechnology in medical applications is an on-going and important effort. The Food and Drug Administration (FDA), National Institute for Occupational Safety and Health (NIOSH), and National Institute of Environmental Health Sciences (NIEHS) are three key research and regulatory organizations that play significant roles in assuring the safety of nanotechnology. The FDA evaluates the potential risks associated with nanomaterials and approves nanotechnology-based products based on their safety and effectiveness. FDA has issued several guidance documents on topics relating to the use of nanotechnology. The NIOSH, a part of the Centers for Disease Control and Prevention (CDC), primarily focuses on the assessment of potential hazards related to nanomaterial exposure in workplaces and setting guidelines for their safe use. The NIEHS, a part of NIH, is dedicated to researching the impact of environmental factors on human health. The three agencies collaborate to understand the risks and benefits of nanotechnology, establish safety guidelines, and provide regulatory oversight to protect the public from potential adverse effects associated with nanomaterial exposure.

To serve the nanotechnology and cancer research communities, the Nanotechnology Characterization Laboratory (NCL) was conceived at the onset of the Alliance and has become a critical intramural infrastructure aiding the efficacy and toxicity characterization of nanomaterials intended for cancer diagnostics and therapeutics. In concert with National Institutes of Standards and Technology (NIST) and FDA, the NCL took the lead role in creating an assay cascade to characterize the physical attributes of nanoscale devices, assess their in vitro biological properties, and evaluate their in vivo compatibility. So far, the NCL has collaborated with more than 125 investigators worldwide, evaluated over 500 unique nanoparticles for cancer applications, and disseminated their methodologies, characterization protocols, and data to the public through the Cancer Nanotechnology Laboratory (caNanoLab) database.