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FDA Aims To Tap Sentinel Data Network For Drug Effectiveness Studies

 
• By Cathy Kelly

New ‘Guardian’ program to monitor post-market effectiveness through the Sentinel electronic data network will take five years to build, FDA’s Woodcock says.

FDA is planning to develop ways of using its Sentinel electronic data network to conduct post-market studies on drug effectiveness in addition to the safety surveillance it is already being used for, Center for Drug Evaluation and Research Director Janet Woodcock announced.

The planned drug effectiveness research program is being called Guardian, Woodcock told the eighth annual Sentinel public workshop Feb. 3. The workshop was convened by the recently-formed Duke Margolis Center...

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