(Source: Mondaq 2014-5-23）
During a May 6 roundtable discussion hosted by the House Energy and Commerce Committee, FDA program directors urged legislators to advance policies that will ease market entry for innovative pharmaceuticals and medical devices. The roundtable was the first of several hearings scheduled for the House Committees 21st Century Cures Initiative, aimed at promoting an ongoing dialogue among legislators, regulators, researchers, and industry leaders to collaborate in accelerating the pace of medical breakthroughs.
At the hearing, Janet Woodcock, director of FDAs Center for Drug Evaluation and Research (“CDER”), discussed developing clinical trial networks to help coordinate the testing of multiple drugs that target a common health condition. She also encouraged legislators to invest in American drug manufacturing, which would help ensure adequate drug supply in the event of an overseas disruption.
Speaking for the Center for Devices and Radiological Health (“CDRH”), Director Jeffrey Shuren focused on the unique device identifier (“UDI”) rule and FDAs desire to integrate data collected from UDIs with electronic health records used by providers. The UDI system gathers information on medical device adverse events, which then can be used to coordinate recalls of similar products and improve patient safety by highlighting known risks. Shuren also discussed the Agencys recent efforts to expedite premarket approval of critical, breakthrough devices—a new program we featured in the last issue of the Jones Day Pharmaceutical & Medical Device Regulatory Update.
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