On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the drug overdose crisis.
FDA performs postmarketing surveillance and risk evaluations on products to identify new adverse events that were not present in the approval process. New information is investigated and may require changes in prescribing information or modification of a Risk Evaluation and Mitigation Strategy (REMS).
