Related Pages Drug Information Summaries 1 NCI's drug information summaries provide consumer-friendly information about certain drugs that are approved by the U.S. Food and Drug Administration (FDA) to treat cancer or conditions related to cancer. Protecting Participants in Clinical Trials 2 A collection of material about the ways in which clinical trials participants are protected before and during the conduct of a study.

Every year, medical researchers develop new cancer treatments or new uses for treatments already on the market. These treatments are most often drugs, chemically produced substances used to treat or prevent disease. But they may also be biologics, treatments that are made from living organisms such as vaccines or recombinant proteins.

The U.S. Food and Drug Administration (FDA ³) is the division of the U.S. Department of Health and Human Services charged with making sure that drugs and biologics are safe and effective before they go on the market. The FDA maintains a list of drugs and biologics ⁴ approved for use with cancer.

FDA regulators face two main challenges during the approval process. First, they must make sure the treatment is safe and effective. For this, regulators rely on the results of clinical trials - research studies that test how well medical treatments or other interventions work in people. (For more information about trials, see What Is a Clinical Trial? ⁵)

The second challenge is to make promising treatments available as quickly as possible to the people most in need of them. Ordinarily this occurs through clinical trials. The FDA may also allow access to an unapproved investigational treatment outside of a clinical trial, if no approved therapy for the disease exists.

This guide will acquaint you with the main parts of the FDA approval process and point you to other resources for learning more about it.

Glossary Terms

In genetics, describes DNA, proteins, cells, or organisms that are made by combining genetic material from two different sources. Recombinant substances are made in the laboratory and are being studied in the treatment of cancer and for many other uses.

A substance or group of substances meant to cause the immune system to respond to a tumor or to microorganisms, such as bacteria or viruses. A vaccine can help the body recognize and destroy cancer cells or microorganisms.