Drug Safety and the drug approval process

Drug Safety a nd t he Drug Approval Process

American consumers benefit from having access to one of the safest and most advanced pharmaceutical systems in the world. The main consumer watchdog for this enterprise is the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER). CDER sets the standards for research in the areas of drug quality, safety and effectiveness to ensure that drugs work correctly and that their health benefits outweigh their known risks

Before a drug can be tested on people, the manufacturing drug company or sponsor performs laboratory and animal tests to discover how the drug works and to evaluate its suitability for human use. This is followed by a series of tests in people to determine whether the drug is safe and whether it provides a real health benefit.

Before a drug can be tested on people, the manufacturing drug company or sponsor performs laboratory and animal tests to discover how the drug works and to evaluate its suitability for human use. This is followed by a series of tests in people to determine whether the drug is safe and whether it provides a real health benefit.

The FDA monitors the side effects and any safety issues after the drug is marketed and used in a much larger population. It also periodically updates the drug’s label and adds warnings, if necessary.

For more information about the FDA and its activities, visit http://www.fda.gov/ForConsumers/default.htm.