Big Tech Helping US FDA With Sentinel Expansion
Amazon, Microsoft, IBM among those helping build new operations and innovation centers for the US FDA's safety surveillance system.
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User fee program inflation adjustment also proposed to be changed to account for only PDUFA-related personnel.
User fee reauthorization negotiators from US FDA and industry divide into subgroups to tackle specific issues before moving to the broader agreement.
CDER Director Woodcock announced that the drug center will soon launch the Drug Risk Management Board, which will coordinate product safety activities among the different offices; Patrizia Cavazzoni, who serves as CDER's deputy director of operations, will chair the board.