Sergey Morev
Themes it raises
2 of the 21 themes in the docket.
Whether benchmark results prove anythingFDA Q9, Q10, Q16
What makes a function high riskFDA Q1, Q2, Q5
FDA questions it names
Questions this filing names by number.
Q1 · The two-axis risk frameworkQ8 · Mapping the risk grid to evidenceQ9 · The benchmarking structure
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