Regulating Nanomedicine Ė Can the FDA handle it, Medicine, Page 5
Regulating Nanomedicine Ė Can the FDA handle it
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possible change in the regulatory status/pathway when products contain nanoscale
Experts continue to criticize the FDA rather lax and uncoordinated effort when it comes to
regulating nanomedicine. All in all, governmental regulatory agencies are in disarray over the
regulation of nanomedicine. The situation is not much different at other global regulatory agencies.
As nanoproducts move out of the laboratory and into the clinic, federal agencies like the FDA [8‚Äź10,
13‚Äź15] and the US Patent & Trademark Office (PTO) [16‚Äź18] continue to struggle to encourage the
development of nanomedicine while imposing some sort of order. Numerous challenges confront
regulatory agencies and important unanswered questions linger (Table 1). All this while a steady
stream of nanoproducts continues to arrive in the marketplace. Given this backdrop, investors have
been cautious and confused as to what route, if any, the FDA will take in regulating nanomedicine.
FDA's delay in addressing nano‚Äźregulation could have a chilling effect on public confidence and
commercialization efforts . So far, the process of converting basic research in nanomedicine into
commercially viable products has been difficult. Securing valid, defensible patent protection from
the PTO [16‚Äź18] along with clearer regulatory/safety guidelines from the FDA [8‚Äź10, 13‚Äź15] is critical
to any commercialization effort. In spite of all these bottlenecks, a large number of FDA‚Äźapproved
nanodrugs have been launched while many more are poised to receive regulatory approval [1, 2].
But, there are currently hundreds of unregulated and unlabeled nanoproducts on the market that
incorporate engineered nanoparticles and nanomaterials. Similarly, tons of these engineered
nanoparticles and nanomaterials continue to be produced annually.
Table 1 - Critical Questions for the FDA Regarding Nanomedicine
Ôā∑ Why has nanomedicine not gained prominence on the FDA's regulatory agenda?
Ôā∑ Are nanomaterials inherently toxic?