US Institute of Medicine urges sweeping changes in FDA drug safety oversight

摘要

A much awaited US Institute of Medicine report recommends significant and sweeping changes in the FDA's regulation and statutory oversight of drug safety.The loM's recommendations include new labelling requirements and advertising limits for newly approved medicines, and mandatory registration of clinical trials and results. It also calls upon Congress to give the FDA new legal authority for postmarketing enforcement, and to substantially increase funding and personnel for the agency's drugs centre.