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Pharmaceuticals / Regulatory Affairs

Final Bids for Sentinel System Due in Weeks, Woodcock Says

May 9, 2019
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Bids are due by the end of the month that FDA officials hope will revolutionize the agency’s Sentinel database, said CDER Director Janet Woodcock at the Food and Drug Law Institute’s annual meeting in Washington, D.C.

CDER officials have already met with some 18 vendors and final bids are due May 24 to manage and build out the agency’s ambitious project, she said.

Sentinel will be broken up into three parts to help the agency manage the reams of data it hopes to capture. One will be involved in “community building”—using chatrooms and external education. Another will focus on analyzing academic methodologies. But the biggest and most important element will be its operations center, where CDER officials want to build the “test bed” for real-world evidence that the agency has dubbed “FDA Catalyst.”

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