What is the FDA’s role?

The FDA serves as a consumer watchdog—it makes sure that safe and effective drugs are available to improve the health of patients who need them. The FDA evaluates new drugs before they can be sold and ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks. The FDA’s review of new drug applications not only prevents unsafe drugs from entering the market, but it provides doctors and patients with the information they need to use medicines wisely.

In addition, the FDA continues to actively monitor and ensure the safety of drugs after approval. Among its post-marketing activities, the agency analyzes reports of adverse reactions submitted by companies and health care practitioners, and in some cases requires pharmaceutical manufacturers to conduct additional post-marketing testing (Phase IV trials) to evaluate long-term effects of approved medicines.