US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’
Acting FDA commissioner says there are a lot of strong forces in the research and pharma industries that could curb efforts to make pandemic-related clinical trial reforms permanent.
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Final FDA guidance also suggests sponsors recruit representative populations and limit exclusions.
Woodcock’s willingness to stay on at US FDA for more than a transitional period after Robert Califf’s expected confirmation as commissioner may depend on exactly the type of authority and tasks he’d be willing to delegate to her. Plus, some other agency personnel updates.
US FDA commissioner-nominee Califf calls for streamlining clinical trial bureaucracy, as well as open access to clinical data.