FDA Research: The Foundation for Sound Regulatory Decisions

FDA Consumer, January-February 2006 | Go to article overview

FDA Research: The Foundation for Sound Regulatory Decisions


The National Center for Toxicological Research (NCTR) plays a critical role in the Food and Drug Administration's mission to promote and protect public health.

The NCTR grew out of the conversion of the Army's Pine Bluff Arsenal to a unique facility for improving consumer protection. President Richard M Nixon announced in January 1971 that the FDA would establish and administer the NCTR at the plant formerly used to produce biological warfare agents.

Located in Jefferson, Ark., about 30 miles south of Little Rock, the facility occupies 504 acres and includes 33 buildings with 1 million square feet of floor space. About 700,000 square feet of that space has been renovated to provide state-of-the-art research laboratories, animal facilities, and Biosafety Level 3 laboratories.

The center, which is the fundamental research arm of the FDA, provides the FDA and other regulatory agencies with the knowledge required to make decisions concerning toxic substances and their effects on human health.

The NCTR conducts peer-reviewed research targeted to develop a scientifically sound basis for regulatory decisions and to reduce risks associated with FDA-regulated products. This research is aimed at evaluating the biological effects of potentially toxic chemicals or microorganisms and developing methods to improve assessment of human exposure, susceptibility, and risk.

The FDA's research arm also is developing and standardizing new technologies, such as genomics, proteomics, metabonomics, imaging, and nanotechnology, to identify and characterize early biomarkers of toxicity in traditional toxicological models.

Rats and mice are used to initially test the safety of FDA-regulated products and there often is uncertainty concerning the value of these predictions using available technology. The application of these new tools in animals and humans will help to more confidently predict the safety of medical products.

In addition, the NCTR is using data collection, interpretation, and storage of information about gene and protein expression (toxicoinformatics) to manage and integrate data from these new technologies to predict an adverse event prior to its occurrence.

The NCTR benefits significantly from collaborations with other FDA centers and other government agencies, academia, and industry. …

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