In his new iniative called "Andy's Take," Andrew von Eschenbach, Commissioner of the US Food and Drug Administration, reveals his position on integrated medicines, notably products such as drug-eluting stents, which hold a blood vessel open while slowly delivering a drug that inhibits scar formation.
"My Take on this action is that it not only emphasizes the value of collaboration within FDA, but more importantly, it previews the future challenge of regulating medical products that are not only combined, but are truly integrated in their function," he said.
"In the future, integrated medical products will be even more complex and more common. For instance, with the introduction of nanotechnology, one might imagine a device like the drug-eluting stent with nano-components that would also monitor gene expression of the scar-forming cells while informing other components to time-release the precise amount of a drug for the optimal balance of healing. This device would integrate the properties of diagnostic monitoring, mechanical support and drug delivery," the Commissioner noted.
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