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Nanomedicine Nanomedicine is an area of biomedical research that seeks to use nanoscale tools to improve health. Current medical uses of nanotechnology include sunscreens, dental-bonding agents, novel wound dressings, and liposomal drug delivery platforms. Nanotechnology products that we should expect to see reach the market during the next few years include the following:
The Terminology of Scale There are 3 scales used to broadly categorize the size ranges for macro, micro, and nanotechnologies:
FDA's Nanotechnology Task Force In August 2006, the FDA initiated the Nanotechnology Task Force (NTF) to help determine appropriate regulatory approaches that would enable the continued development of innovative, safe, and effective FDA-regulated products that use nanoscale materials. As an initial assignment, the NTF was asked to identify and recommend ways to address any knowledge or policy gaps that exist to better enable the agency to evaluate safety aspects of nanomedicine products. The NTF has completed this assignment and released a comprehensive report on July 25, 2007, which recommends among other things, that FDA consider developing guidances and take additional steps to better understand the potential risks and benefits of therapeutics using nanotechnology. Regulation Strategies For the most part, FDA and industry experts believe that nanotechnology products present challenges similar to those FDA faces for products of other emerging technologies. The experts also recognize, however, that these challenges may be magnified because product safety and effectiveness might change dramatically as size goes up or down within the micro/nanoscale, thus adding additional complexity to the product review. FDA expects that many nanotechnology therapeutics will span the regulatory boundaries between drugs, medical devices, and biologics. Initially, nanomedicine will likely be regulated under the rules established for combination products. Consistent with this similar precedent, FDA is expected to have broad latitude to make jurisdictional determinations and to implement preclinical and clinical testing requirements which may be significantly more burdensome for nanoscale products than conventional therapies. Rather than providing a prospectively specified framework for the regulation of nanotechnology, FDA will likely evaluate each new product on a case-by-case basis. Over time, the agency will presumably attain the necessary understanding of this complex science to develop guidelines covering a wide range of regulatory considerations. This process will probably evolve in a similar manner as with FDA's experience during the past decade with the regulation of combination products. As an example, consider FDA's development of the critically important paradigm of Primary Mode of Action (PMOA). This science-based concept (which guides the determination of combination product jurisdiction) illustrates how, with the rapid evolution and deeper understanding of the science itself, a clarifying taxonomy emerges which reflects a convergence of thinking among FDA, industry, and the broader scientific community. The taxonomy ultimately serves as a framework for product categorization, thus providing industry and investors with a comforting measure of regulatory predictability. Safety First -- The Potential for New and Currently Uncharacterized Nanoscale Biological Interactions Perhaps
of greatest relevance to new products regulated by FDA is what the
current For conventional drugs/biologics/devices, there is a relatively long history of product characterization and validated test methods which have provided a robust understanding of the interactions of molecular classes (compounds containing particular structures or functional groups) and also medical device materials with biological systems. For nanomaterials, however, a prudent assumption is that these well-established characterization and testing principles will be subject to new and potentially vigorous skepticism by the FDA. Important testing and characterization considerations are described in the table below:
Broadly summarizing the above considerations, it will likely be necessary for sponsors to "cast a wide net" in order to sufficiently demonstrate product safety. Unlike conventional therapeutics with a long and well-established safety history, FDA will expect nanomedicines to undergo comprehensive testing designed to rule-out the potential for new types of adverse biological interactions. FDA Nanotechnology Contacts
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