The Center for Drug Evaluation and Research

The CDER is responsible for the evaluation of drugs, both those that are available only by prescription and those that are available over the counter. In evaluating drugs, the FDA uses a generally accepted sequence of tests. First, the effects of chemicals that may make up a drug are tested in laboratory settings on cell cultures or other compositions that might be involved in a particular disease. If these tests prove promising, then the chemicals are tested in at least two different nonhuman species that act as models to assess the action of the chemical in a biological system. It is only after these initial steps that a potential new drug is tested in humans according to a three-phase protocol. In Phase I, tests are made for adverse effects on a small group of healthy volunteers. If there are no adverse effects—or the effects are acceptably minor—the effectiveness of the drug on the relevant disease or condition is tested in patients suffering from that disease or condition in Phase II. If the drug shows adequate effectiveness, it proceeds to Phase III, which attempts to define specific criteria for use of the drug—that the drug is safe and effective when used in appropriate doses. The Phase III studies are intended to be comprehensive, involving potentially many thousands of patients who participate in a study that permits comparison with a control substance.

This basic structure is expected to be followed with drugs that are developed using nanotechnology. Further discussion of this is provided in a later section, but the effect of nanostructures will first be evaluated in laboratory settings on cultures, then in animal models, and then using the three-phase protocol for human studies.

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