What does the FDA do?

The FDA is a government agency that is responsible for making certain that the food we eat and the drugs we take are safe. The FDA does not make drugs or directly test drugs to determine if they are safe and effective. The FDA's role is to oversee the research conducted by pharmaceutical companies, university research centers, and physicians to make certain that federal regulations governing research are being followed.
The FDA requires that the drug company's plan must be reviewed by community research review board (IRB), and that patients participating in the clinical trial are informed about the trial and consent to participate. Once the drug company has completed its clinical trials, the data are tabulated and submitted to the FDA in an application known as a New Drug Application (NDA). The FDA evaluates the outcomes reported in the NDA and determines whether the new drug will be approved and made available to patients in the United States. In order to be approved, the drug must be safe and effective.