Existing FDA Regulations That Apply to Nanomaterial Containing Products

The FDA has specific guidance/requirements in place for most products. These guidance documents can be accessed on the FDA's website (http://www.fda.gov/oc/industry/default.htm). These requirements apply to all products, whether they contain nanomaterials or not. Existing requirements are therefore considered to be adequate at this time for most nanotechnology pharmaceutical products.

In the following section, there will be a brief description of the current preclinical requirements for the submission of most drugs, to highlight why we believe that our current regulations are adequate for the evaluation of the types of nanotechnology products that have been reported as being "close" to submission to the agency as an investigational new drug (IND).

Within CDER, the preclinical requirements for approval to market pharmaceutical products include both short-term and long-term toxicity testing in rodent and non-rodent species. Specifically, the types of studies conducted by pharmaceutical manufacturers prior to New Drug Application (NDA) submission include pharmacology (mechanism of action), safety pharmacology (functional studies in various organ systems, most notably the cardiovascular system), absorption, distribution, metabolism, and excretion (ADME), genotoxicity (potential to cause mutations in both in vivo and in vitro assays), developmental toxicity (to assess effects on reproduction, fertility and lactation), irritation studies (to assess local irritation effects), immunotoxicology (to assess effects on the components of the immune system), carcinogenicity (to assess the capacity of drugs to induce tumors in animal models) and other possible studies (specific studies for a product being developed). The current battery of tests, as listed above, is therefore considered to be adequate because of the following reasons: the studies use high dose multiples of the drug (usually three doses, one that results in low, one that results in medium and one that results in high toxicity), at least two animal species are used (usually one rodent and one non-rodent), extensive histopathology is conducted on most organs (where most organs are removed, fixed, stained and viewed under the microscope to assess if there are structural changes that may have resulted from damage to the organs), functional tests are conducted to assess if there are effects on specific organ systems (such as the heart, brain, respiratory system, reproductive system, immune system, etc.) and drug treatments in animals can be for extended periods of time (up to two years for carcinogenicity studies).

Additional studies might be requested based on drug-specific considerations and on a case-by-case basis. Therefore, as for other drugs, nanotechnology products will be handled on a case-by-case basis, depending on the characteristics of the particular product being developed. As research provides additional understanding with regards to the toxicity of nanomaterials, the FDA may require additional toxicological tests to ensure the safety of the products it regulates.

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