Regulating Nanomedicine Ė Can the FDA handle it, Medicine, Page 10
Regulating Nanomedicine Ė Can the FDA handle it
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(CDRH). Obviously, categorizing nanoproducts according to this legal FDA classification is critical
due to the widely divergent regulatory approval standards employed by the FDA [9, 23]. However,
certain therapeutics are “combination products,” which consist of two or more regulated components
(drug, biologic, or device) that are physically, chemically or otherwise combined or mixed to produce
a single entity. Here, the FDA's category‚Äźbased approval process has resulted in inconsistency .
It is difficult to predict how nanoproducts will be regulated. Size changes within the
nanoscale and the potential unpredictability therefrom are likely to add complexity to the FDA
review process. The traditional product‚Äźby‚Äźproduct regulatory model that the FDA currently
employs may not be effective for all nanoproducts as it may be difficult to classify them into one of
the available traditional classifications (i.e., drug, device, biological or combination product).
However, in many cases, the FDA may view nanoproducts as technologically overlapping
(miniaturization will blur distinctions between different categories) from a review perspective, and
therefore, consider them as complex combination products. These are likely to pose challenging and
complex regulatory review issues for the FDA .
RECOMMENDATIONS FOR THE FDA
There are numerous challenges confronting regulatory agencies like the FDA regarding reform
of regulatory guidance for nono‚Äźtoxicological evaluation. Among these are limited availability of
information correlating physicochemical properties of nanomaterials to risks, and a lack of validated
preclinical screens and animal models for the assessment of nanomaterials . The toxicity of many
nanoscale materials will not be fully apparent until they are widely distributed and their exposure is