Drug safety refers to the process by which the Food and Drug Administration (FDA) learns about the safety profile of a drug before approving it to be marketed to the public and monitors its safety once it is in the marketplace. All medicines have risks. According to FDA, injuries from approved medicines are one of the top 10 causes of death in the United States.

FDA uses state-of-the-art tools and techniques to detect rare and unexpected risks more rapidly and take corrective action more quickly. These include testing and surveillance of drugs, and developing policies, guidance and standards for drug labeling, current good manufacturing practices, clinical and good laboratory practices, and industry practices that demonstrate that drugs are safe. Drug risks include product quality defects, known side effects, medication errors, and uncertainties. Product quality defects are controlled through good manufacturing practices, monitoring and surveillance. Most injuries and...