Research At The Fda On Nanotechnology

Although the FDA is a regulatory agency, it is also engaged in a number of research activities. However, the FDA recognizes that science supported by research provides the foundation for sound regulation. As such, the FDA is interested in research projects that can address specific regulatory needs. As an example, FDA has a grants program in support of orphan products research and development. The FDA does not have a grants program to support other research in non-FDA laboratories. Nevertheless, in several of its Centers the FDA conducts research to understand the characteristics of nanomaterials and nanotechnology processes. Research interests include any areas related to the use of nanoproducts that the FDA needs to consider in the regulation of these products.

Although many FDA Centers are engaged in some nanotechnology research activities, only some of the specific projects that are currently ongoing are listed below. The research projects, which happen to be conducted by the Center for Drug Evaluation and Research (CDER), include:

1. Particle size determination in marketed sunscreens with TiO2 and ZnO nanoparticles. Sunscreens are considered drugs in the U.S., and although some undergo a premarket FDA review, others are marketed under over-the-counter (OTC) monographs that outline the active ingredients that the FDA has found to be safe and effective, as well as labeling that is truthful and not misleading. TiO2 and ZnO used in sunscreens are therefore manufactured according to OTC monographs, and these monographs do not specify particle size. As a result, a manufacturer can formulate a sunscreen using particles of TiO2 and ZnO that may or may not be in the nano size range. Therefore, to assess the particle size of TiO2 and ZnO in currently marketed sunscreens, CDER has undertaken a research project, in collaboration with NIST.

2. Another project focuses on manufacturing various nanoformulations in our laboratories and characterizing the physical and chemical properties of the nanoparticles in these formulations, including evaluating the effects of excipients on the measured parameters, the effects of preparation methodology on the measured parameters, and the impact (if any) that process and formulation variables may have on nanotechnology product characteristics and stability.

3. Another project is studying the in vivo effects of selected nanoparticles, using validated animal models. The toxicity of the same nanoparticles will also be evaluated, using various in vitro systems.

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