What are some of the challenges we face in managing the risk of medical products?
First and foremost are the tremendous advancements in science and technology. Both government and the private sector have invested enormous resources in biomedical research and biotechnology. The result of this investment is, and will continue to be, a wealth of new products and technologies that will be presented to the FDA for our review and approval before they are introduced into the marketplace. In order to make these judgements, it is essential that the FDA have the scientific talent to adequately assess the safety and effectiveness of these novel products and technologies. Our scientists must be current in their fields of expertise, quick learners in new areas, and have the creativity and ability to collaborate with other scientists in the FDA and outside the agency. In short, we must be able to anticipate and access the cutting-edge science that will be needed to regulate the products of future technology. Our scientists help to establish standards for product performance and p