This month, the FDA released its first framework for the regulation and oversight of nanotechnology, as a joint collaboration with the National Economic Council, the Office of Management and Budget, the Office of Science and Technology Policy and the Office of the U.S. Trade Representative. This is a "first step" towards regulating this new and innovative technology.
The document is intended to summarize generally applicable principles relevant to promoting a balanced, science-based approach to regulating nanomaterials and other applications of nanotechnology “in a manner that protects human health, safety and the environment without prejudging new technologies or creating unnecessary barriers to trade or hampering innovation,” the authors wrote.
“With this guidance, we are not announcing a regulatory definition of nanotechnology,” said FDA Commissioner Margaret A. Hamburg, MD. “However, as a first step, we want to narrow the discussion to these points and work with industry to determine if this focus is an appropriate starting place.”
As the commissioner suggests, this is a “first step” toward regulatory definitions, which will be particularly relevant in the preclinical imaging space, which has experienced an explosion of research with nanotechnologies.
In this rapidly evolving space, the regulators are scrambling to catch up with the science. For instance, in May, researchers at Memorial Sloan-Kettering Cancer Center, along with collaborators at Cornell University and Hybrid Silica Technologies, received approval for their first Investigational New Drug Application from the FDA for an ultra-small inorganic (silica) nanoparticle platform for tumor targeting and for the treatment of cancers in the future.
However, it shows some great promise, especially in cancer detection. For instance, a study published in April demonstrated that a class of engineered nanoparticles—Raman-silica-gold-nanoparticles—are safe when administered by two alternative routes in mouse models, and these nanoparticles could potentially detect colorectal cancer.
If you have other research that involves preclinical imaging using nanotechnology, please let us know.