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New drug regulator confronts major challenges
Modern Healthcare

An opioid abuse epidemic fueled by prescription drugs. Public outcry over high drug prices. A huge backlog of generic drug applications. Industry stakeholders pressing for faster approvals.

Former clinical researcher Dr. Robert Califf recently took over a U.S. Food and Drug Administration that is heading into an era of unprecedented challenges and change. The decisions he will make over the next few years—assuming he holds on to his job in the next administration—will redefine how drugs, medical devices, tobacco, food safety and controlled substances are regulated in the 21st century.

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