ABSTRACT
But regulators are first to acknowledge their failings, and many are at work to address these shortcomings. The FDA has invested heavily in new in-house nanotechnology regulatory science programs, aimed at ramping up new methods to profile and test nanomaterials in vitro and vivo. The National Cancer Institute’s Nanotechnology Characterization Laboratory (NCL) has examined nanomaterials and their complexities since 2004. Every year, it accepts a dozen or so potential nanotherapeutics developed from labs nationwide and runs a battery of tests that serve to both assess those drugs and add to its growing body of assay protocols and troublesome manufacturing pitfalls such as sterility and batch-to-batch variability-all of which it shares with the science community and FDA. In the past ten years, it has characterized nearly 300 different nanomaterials and sent six on to clinical trials. Meanwhile, the information and standards that it has gathered have begun to unofficially reshape not only the FDA’s own review practices but strategies internationally.
