The FDA derives its regulatory authority primarily from the Federal Food, Drug, and Cosmetic Act and its amendments, including the Food and Drug Administration Amendments Act of 2007, which authorized Risk Evaluation and Mitigation Strategy programs. The FDA can approve drugs, require post-market safety studies, impose REMS restrictions, and modify or remove those restrictions when safety data warrants. Courts review FDA decisions under the Administrative Procedure Act arbitrary-and-capricious standard, but there is ongoing legal debate about how much deference courts should give to FDA scientific judgments.