
Analyzing Nano Drugs
FDA details efforts to evaluate potential risks from use of nanomaterials in drug products and discuss analytical considerations, impact on stability, safety, and toxicology effects.
Manufacturers, scientists, and regulators are examining methods for characterizing nanomaterials in drug formulation and production and the need for clear US and international standards in this area.
This program is timely because of growing interest in FDA moving beyond the examination of nanomaterials in sunscreens and other topicals to opportunities for improving the delivery of treatments for cancer and other serious conditions. The New York Academy of Sciences held a conference in November 2013 on the application of nanotechnology to nanomedicine, featuring experts from the National Characterization Laboratory of the National Cancer Institute discussing the development of new cancer therapies and product characterization. FDA’s 2013 nanotechnology regulatory science research plan outlines a range of activities that would improve staff training, expand laboratory facilities and promote collaborative research on nanotechnology. And the recently issued federal National Nanotechnology Initiative’s 2014 strategic plan describes FDA nano-related initiatives, pointing out the need for more scientific information to better detect and predict the potential impact of nano on drug safety, effectiveness and quality. An
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