You may know the FDA is responsible for approving new drugs, such as prescription, generic, biosimilars, and over-the-counter drugs, and ensuring those drugs are safe, high quality, and work the way they’re supposed to. But our work doesn’t end there. We continue to monitor approved drugs for safety and quality for years to come. Learn more about our role in the regulation of these drugs.
Prescription drugs go through many important steps and phases before they’re approved by us. Research, data, and evidence must show that each drug is safe and effective for its intended use. Learn more about FDA’s approval process from beginning to end.
FDA continuously monitors real-time data from patients, drug manufacturers, and health care professionals, including reports of adverse reactions to prescriptions. Based on this data, we may update drug labeling, or, in rare cases, request a drug recall. Learn more about FDA’s process for the continuous monitoring of approved drugs.
