Prior to the Food and Drug Act of 1906, no laws guaranteed the quality of medicines, and no regulations required a doctor's prescription for medications. Since 1962, the Food and Drug Administration (FDA) has required that drugs be evaluated as safe and effective. Safe means that the benefits of a particular therapy have been determined to outweigh the risks. Safe does not mean that a therapy is necessarily free of adverse effects. Effective means that a therapy meets pre-defined standards of efficacy. FDA seeks to balance public safety with public desire to have access to promising new drugs, especially for life-threatening illnesses.

Today, FDA is charged with reviewing oncology drugs, biologics, and devices. Depending upon the evidence, FDA approves the usage of new products for specific indications. All products must be safe and effective, and the benefits must be demonstrated to outweigh the risks. To learn more about the general approval process for new cancer drugs, click here.