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At the FDA's request, this report emphasized the importance of studying children's drug safety and the impact of drugs on children. The development system for children's drugs differs from that of adults. Since the United States passed two laws to incentivize pharmaceutical companies to conduct research on children's medicines, the United States has made great progress in researching children's drug safety.
However, the American Medical College believes that studies involving children are still limited, especially in certain areas such as the use of neonatal drugs and the safety and efficacy of children's long-term use of drugs. The agency has recommended that the U.S. Congress and the FDA place some pressure on pharmaceutical companies to conduct studies on long-term childhood drugs that may pose security risks. It also recommends giving FDA the right to impose sanctions on research that has been delayed for no reason.
FDA promotes the supervision of children's drug clinical trials
According to a new report from the American College of Medicine (IOM), the US regulatory agency has supervised the clinical trials of children's medicines, and the FDA can promote pharmaceutical companies' long-term safety testing of children's medicines more favorably.