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FDA Scales Back Near-Term Goals For Sentinel Postmarket Data Network

 
• By Cathy Kelly

FDA’s Janet Woodcock said the agency has not been able to overcome budgetary restrictions that hamper previously discussed plans to develop the Sentinel postmarket drug safety surveillance system into a much broader national resource.

FDA has scaled back plans to significantly broaden the scope and type of activities that could be supported by its Sentinel electronic data network in the near term, Center for Drug Evaluation and Research Director Janet Woodcock disclosed Jan. 14 during the annual Sentinel public workshop in Washington, D.C.

Instead, Sentinel will continue to focus on medical product safety surveillance for FDA in the immediate future, she said. The workshop was convened by the Engelberg Center for Health Reform...

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