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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A group would look at the diseases that need codes and which to add initially, then consider updates to the code nomination process, in an effort to lower costs for rare disease patients.
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.