FDA to steer nanotech

With more and more companies touting nanotechnology as a means to improve drug delivery, US Food and Drug Administration (FDA) officials are developing guidelines for companies to ease such products through the regulatory process. The goal is “not to create additional hindrances to developers but to identify and provide infrastructure for the development of products,” said Nakissa Sadrieh from the FDA's Center for Drug Development during an agency-sponsored public meeting on nanotech, held last month in Rockville, Maryland. Representatives of several biotech companies see the agency's approach as promising but urge that the guidelines be neither reflexive nor rigid. “We're not seeking to change the regulations or short-circuit anything at FDA, and we're perfectly fine with the collegiality,” says Lawrence Tamarkin of Rockville, Maryland-based Cytimmune Sciences, a company that attaches tumor necrosis factor to nano-gold particles for use in cancer treatment. “But we want no additional barriers put up.” Whereas David Hobson of Houston-based nanoTox suggests the FDA follows a strict case-by-case approach in regulating nanotech-based therapeutic products, Kathleen Pirollo, who works with Washington, DC-based SynerGene Therapeutics, urges the agency to recognize that “soft” nanotech-based drug-delivery systems, such as those that depend on lipid bilayers, should not be regulated along with inorganic materials.


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Fox, J. FDA to steer nanotech. Nat Biotechnol 26, 1060 (2008). https://doi.org/10.1038/nbt1008-1060a

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