December 1, 2011

HOWARD LOVY: FDA: Regulate Nanotech First, Learn what it is Later? “The FDA, in cautionary mode, has come up with a meaningless nanotech threshold of 1,000 nanometers. The genius who decided on that number in a draft guidance on nanomaterial regulation has the biotech industry scratching its collective head over this new math. . . . There are many materials in existing pharmaceuticals that already are smaller than this threshold, such as liposomes, emulsions and suspensions, that are already proven to be safe and may contain nanoscale particles, but are not the new, spooky, scary, magical nanomaterials that has regulators around the world worried. It’s surprising, because the FDA has been studying nanomaterials for a long time and I’d have thought that they would at least know what it is they want to regulate, before they begin regulations. Not a good start to government oversight of nanobiotech.”

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